Description:FIELD OF INVENTION
The present invention relates to a portable cardiac risk assessment tool and system for cardiac stress test, which includes a portable ECG equipment along with the portable stepper. The present invention relates to the recording, processing, analysis and assessment of the data generated and recorded by the cardiac risk assessment tool and system for review and interpretation by a remote physician/doctor.

BACKGROUND OF INVENTION
The cardiac stress test involves several elements, which can help reveal a blockage in several ways:
• Blood oxygen level monitoring: When the blood flow is obstructed (a condition known as ischemia), the amount of oxygen delivered to the heart and carried from the lungs is decreased.
• Pulse and blood pressure monitoring: When the blood flow is partially obstructed by plaque, the heart has to work harder to pump blood through the narrowed vessels.
• Electrocardiogram (ECG): These same effects alter not only the heart rate but the heart rhythm as well. With CAD, the changes are characteristic and may be identified with an ECG. In addition to diagnosing CAD, a stress test can often tell us how significant the blockage is (referred to as a functional capacity evaluation).
For instance, if signs of ischemia develop with little exercise, the blockage is likely significant and in need of aggressive intervention. Ischemia occurring at higher levels of exercise is usually less significant and may alter the approach to treatment. Periodic stress tests can also be used to monitor the progression of congestive heart failure (where the heart is not pumping blood as it should) or assess how well the patient is r
In addition to diagnosing CAD, a stress test can often tell us how significant the blockage is (referred to as a functional capacity evaluation). For instance, if signs of ischemia develop with little exercise, the blockage is likely significant and in need of aggressive intervention. Ischemia occurring at higher levels of exercise is usually less significant and may alter the approach to treatment. Periodic stress tests can also be used to monitor the progression of congestive heart failure (where the heart is not pumping blood as it should) or assess how well the patient is recovering from a heart attack ecovering from a heart attack.
AU 2021100060 A4 discloses relates to a portable real time ECG monitoring system. The designed system is a portable device having a small analog front end circuit, a microcontroller unit (Arduino Mega2560), and display and storage unit. The proposed system acquires the signals using sensor/electrodes placed on the surface of the skin and display these real time signals on TFT LCD screen. The microcontroller programs also calculate and display heart rate. The device is equipped with a memory card that stores a person's ECG data for further analysis.

US 2013-0079655 A1 discloses a portable electrocardiograph includes a sensing unit and an process platform. The sensing unit having a signal wire is arranged to a patient for sensing the cycle of heart beat. The process platform having an application program serves to process and analyze the cycle of heart beat sensed by the sensing unit, the process result wil' be recorded and displayed. The process result will be transmitted through wire, wireless, Bluetooth transmission so that the initial symptom can be delivered to medical personnel. The process result can also be transmitted to data base of hospital server through network for advanced analysis so as to perform further diagnostic and treatment. The portable electrocardiograph is easily carried by patients so as to apply a self-diagnostic in time and inform medical personnel the latest condition for a complete diagnostic.

Consequently, there existed a need in the art to provide for an easy to use and efficient portable stepper and portable ECG machine to conduct the stress test in the safety and comfort of one’s home. It is an object of the invention to provide an efficient way of monitoring the cardiac stress that is less time consuming, wherein the stress test results can be achieved within 20 minutes at the convenience of user’s home.

Further, it is an object of the present invention to provide the guidance of a doctor who is always available online looking at live ECG and the audio video call is recorded for future reference.
It is the object of the present invention to provide for a way for completely digital data collection, processing and analysis including ECG reports through Cardiotrack portable ECG technology.
The present invention also fulfils the need in the art for immediate assistance and assessment in case of symptoms, such as chest pain, shortness of breath or palpitations, to determine whether they are coming from the heart.
SUMMARY OF THE INVENTION
The present invention relates to to a portable cardiac risk assessment tool and system for cardiac stress test, which includes a portable ECG equipment along with the portable stepper. The present invention relates to the recording, processing, analysis and assessment of the data generated and recorded by the cardiac risk assessment tool and system for review and interpretation by a remote physician/doctor.
Heart disease is a catch-all phrase for a variety of conditions that affect the heart’s structure and function. Coronary heart disease is a type of heart disease that develops when the arteries of the heart cannot deliver enough oxygen-rich blood to the heart. It is the leading cause of death in the United States.

Coronary heart disease is often caused by the buildup of plaque, a waxy substance, inside the lining of larger coronary arteries. This buildup can partially or totally block blood flow in the large arteries of the heart. Some types of this condition may be caused by disease or injury affecting how the arteries work in the heart. Coronary microvascular disease is another type of coronary heart disease. It occurs when the heart’s tiny blood vessels do not work normally.

Symptoms of coronary heart disease may be different from person to person even if they have the same type of coronary heart disease. However, because many people have no symptoms, they do not know they have coronary heart disease until they have chest pain, a heart attack, or sudden cardiac arrest.
Therefore it is recommended that the screening tests and risk assessments for coronary heart diseases should begin at around age 20 even if the person does not have any symptoms or coronary heart disease. Children may need screening if they have risk factors, such as obesity, low levels of physical activity, or a family history of heart problems.
The object of the present invention is to provide an easy to use and efficient cardiac risk assessment system. Furthermore, it also offers consultation from a remote doctor.
In one embodiment of the invention, the results from the cardiac risk assessment test help to assess symptoms, such as chest pain, shortness of breath or palpitations, and to determine whether they are coming from the heart.
In another embodiment of the invention, the system can be used to detect if enough blood flows to the heart as the patient gets more active, and helps learn how heart medications are working.
In yet another embodiment of the invention, the system is used to find out if it's likely that the user has coronary heart disease and needs more testing and to identify abnormal heart rhythms. The system also helps to develop a safe exercise program.
There are several advantages of opting for the portable stress test as described including easy availability of the stress test facility, cost effectiveness and that it doesn’t require hospital admission.
According to another aspect of the invention, Conventional print based ECG equipment can be replaced with a portable, Bluetooth and mobile connected ECG equipment for real time data recording and analysis. The recording can be transmitted to the remote physician for review and interpretation.
BRIEF DESCRIPTION OF DRAWINGS
Figure 1. is diagram of system for portable cardiac risk assessment
Figure 2. is a flowchart of process for conducting the cardiac risk assessment test

DETAILED DESCRIPTION

The following description with reference to the accompanying drawings is provided to assist in a comprehensive understanding of exemplary embodiments of the invention as defined by the claims and their equivalents. It includes various specific details to assist in understanding but these are to be regarded as merely exemplary. Accordingly, person skilled in the art will recognize that various changes and modifications of the embodiments described herein can be made without departing from the scope and spirit of the invention. In addition, descriptions of well-known functions and constructions are omitted for clarity and conciseness. The terms and words used in the following description and claims are not limited to the bibliographical meanings, but, are merely used by the inventor to enable a clear and consistent understanding of the invention. Accordingly, it should be apparent to the person skilled in the art that the following description of exemplary embodiments of the present invention are provided for illustration purpose only and not for the purpose of limiting the invention as defined by the appended claims and their equivalents.
It is to be understood that the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise.

The present invention discloses a portable cardiac risk assessment device and cardiac risk assessment system in accordance with the various aspects of the present invention.
Coronary Artery Disease (CAD) is caused by plaque, made up of cholesterol and other substances, buildup in the walls of the arteries that supply blood to the heart (called coronary arteries) and other parts of the body. This buildup causes the inside of the arteries to narrow over time, which can partially or totally block the blood flow; atherosclerosis.
For patients at high risk for heart disease or those who already have symptoms, a doctor uses various tests to diagnose CAD.
A cardiac stress test (also referred to as a cardiac diagnostic test, cardiopulmonary exercise test, or abbreviated CPX test) is a cardiological test that measures the heart's ability to respond to external stress in a controlled clinical environment. The stress response is induced by exercise or by intravenous pharmacological stimulation. Exercise-induced stressors are most commonly either exercise on a treadmill or pedalling a stationary exercise bicycle ergometer. The level of stress is progressively increased by raising the difficulty (steepness of the slope on a treadmill or resistance on an ergometer) and speed. Once the stress test is completed, the patient generally is advised to not suddenly stop activity but to slowly decrease the intensity of the exercise over the course of several minutes. The test administrator or attending physician examines the symptoms and blood pressure response. To measure the heart's response to the stress the patient may be connected to an electrocardiogram (ECG); in this case the test is most commonly called a cardiac stress test but is known by other names, such as exercise testing, stress testing treadmills, exercise tolerance test, stress test or stress test ECG.
The American Heart Association recommends ECG treadmill testing as the first choice for patients with medium risk of coronary heart disease according to risk factors of smoking, family history of coronary artery stenosis, hypertension, diabetes and high cholesterol. In 2013, in its "Exercise Standards for Testing and Training", the AHA indicated that high frequency QRS analysis during ECG treadmill test have useful test performance for detection of coronary heart disease.
The present invention discloses a cardiac stress test is used to evaluate the status of the cardiovascular system, which comprises both heart and blood vessels. It does so by comparing the circulation at rest with the same measurements taken at maximum exertion. While the primary aim of the test is to detect abnormalities suggestive of CAD, it can also be used to monitor the health of people with other forms of heart disease. CAD occurs when the walls of a coronary artery (an artery that feeds the heart) begin to harden, thicken, and accumulate plaque. This is a condition known as atherosclerosis.
Over time, the blockage can impede blood flow and may eventually lead to a heart attack or stroke. The challenge with CAD is that, even with a partial blockage, the heart may still receive an ample supply of blood while at rest. It is only when the heart is placed under stress that the effects of the blockage may be seen and felt. A stress test can estimate your risk of having heart disease. A doctor or trained technician performs the test. They’ll learn how much your heart can manage before an abnormal rhythm starts or blood flow to your heart muscle drops.
There are different types of stress tests. The exercise stress test -- also known as an exercise electrocardiogram, treadmill test, graded exercise test, or stress EKG -- is used most often. It lets the doctor know how the person’s heart responds to being pushed. The person walks on a treadmill or pedal a stationary bike which keeps getting more difficult as the person goes. Meanwhile the electrocardiogram, heart rate, and blood pressure of the person will be tracked throughout.
Further, the present invention discloses a new, comparable but more efficient system to achieve cardiac risk assessment while catering to the challenges that were faced in the conventional method.
Generally, The cardiac stress test is used to evaluate the status of the cardiovascular system, which comprises both heart and blood vessels. It does so by comparing the circulation at rest with the same measurements taken at maximum exertion. While the primary aim of the test is to detect abnormalities suggestive of CAD, it can also be used to monitor the health of people with other forms of heart disease. CAD occurs when the walls of a coronary artery (an artery that feeds the heart) begin to harden, thicken, and accumulate plaque. This is a condition known as atherosclerosis. Over time, the blockage can impede blood flow and may eventually lead to a heart attack or stroke. The challenge with CAD is that, even with a partial blockage, the heart may still receive an ample supply of blood while at rest. It is only when the heart is placed under stress that the effects of the blockage may be seen and felt.
The present invention teaches a simpler portable stepper device that can replicate the inclination of the treadmill through resistance of the stepper and running speed of the treadmill through more steps on the stepper. This portable stepper device can be used as replacement to the treadmill in the conventional method. The inclination and speed data on treadmill needs to be translated to the resistance value and number of steps on the stepper.
The present invention discloses a cardiac risk assessment systemn that includes a-
a. portable bluetooth Cardiotrack ECG machine
b. portable bluetooth blood pressure monitor
c. portable stepper with steps and calorie count
d. connected doctor through cloud calling to observe the process
e. consolidated report with ECG signals, heart rate and MET score (standard for TMT test outcome)
The portable stepper device can replicate the inclination of the treadmill through resistance of the stepper and running speed of the treadmill through more steps on the stepper. The inclination and speed data on treadmill needs to be translated to the resistance value and number of steps on the stepper. It records -
1. various speed, inclination values, calories burnt and heart rate on the treadmill for 3 minutes interval.
2. various step counts/minute, resistance values, calories burnt and heart rate on the stepper for 3 minutes interval.
Further, the data will then be compared to derive an equation and translate the below values –
• Speed of treadmill to Number of steps per minute on the stepper
• Inclination of the treadmill to resistance of the stepper
• Heart rate on the tread mill for a particular speed and inclination to the heart rate on the supper for a particular steps/minute and resistance
The present invention makes use of the portable bluetooth and mobile connected ECG equipment for real time data recording and analysis. ECG raw data is captured and transmitted from the device to the Cardiotrack Android App.
The raw ECG data is then processed with specific filters to remove signal noise, ECG baseline drift, muscle artifacts, movement artifacts and performing signal correction for clean ECG while the patient is on the stepper.
This recorded data can then be transmitted to the remote physician for review, interpretation and assistance as and when required. The transmission of the running ECG from the device to the app and from the app to the cloud and thereby to the remote doctor is done for real time analysis and making assessment.
Further, the calculation of heart rate from the running ECG is made possible. As soon as the stress test is over and ECG recording is closed, a report with pre-test, during-test and post-test ECG comparison report will be generated in the PDF format. This report can then be pushed to the consultant physician for their remarks.
Figure 1 diagramatically represents an example of the system (100) for conducting the stress test for cardiac risk assessment wherein the patient is hooked with the ECG while the technician monitors the process. The signals are transmitted in real time to the dotor who might be at a remote location. Further, cloud computing of the raw data generated is done and the reports can be accessed by the doctor.
Figure 2
Once, the technician the stepper and the 12 lead ECG kit is set up along with the software on a phone at the home of the patient. The technician interviews the patient for basic health including any cardiac ailment history. A consent form is subsequently signed by the patient. Patient’s blood pressure and pulse are captured and recorded. A doctor is connected over video call to monitor the process.
At 210, the resting 12 lead ECG and Blood Pressure readings are captured. If ECG and Blood Pressure readings are normal and approved by the online doctor, the patient is asked to step onto the STEPPER for cardiac stress test. The patient is then asked to step onto the stepper, at 220, for cardiac stress test while the ECG is continuously captured and while doctor is monitoring the progress on the camera along with the ECG signal on his/her system. The patient is instructed to increase the speed of peddling to induce stress on the heart, at 230. ECG and heart rate are automatically recorded and transmitted to the remote doctor. Over few minutes the peddling slows down due to fatigue. The heart rate shoots up from resting heart rate to peak activity heart rate and gradually starts to come down, at 240.
Within 0-5 minutes, depending on the comfort level of the patient, at 250, the patient is asked to step down from the stepper. Resting ECG and Blood Pressure are captured for the next 2 minutes while the patient is in sitting position. The consolidated report is generated, at 260, by the software along with the snapshots of the ECG and heart rate. METS is calculated based on the calories consumed during the exercise. Calorie count is captured from the stepper as soon as the patient steps down from the machine. The signed Cardiac Stress Assessment Report is generated, at 270, by the software and shared with the patient within minutes.

Calculating MET
A MET is a ratio of our working metabolic rate relative to our resting metabolic rate. Metabolic rate is the rate of energy expended per unit of time. It’s one way to describe the intensity of an exercise or activity. One MET is the energy we spend sitting at rest — our resting or basal metabolic rate. So, an activity with a MET value of 4 means we are exerting four times the energy than we would if we were sitting still.
1. Calculating MET from calories consumed -
METs = (calories burned per minute)/(3.5 x (body weight in kilograms) / 200)
2. Calculating MET from time spent on tread mill test (for women) -
METs_max = (4.38 * T - 3.9) / 3.5
3. Calculating MET from time spent on tread mill test (for men) -
METs_max = (14.8 - (1.379 * T) + (0.451 * T²) - (0.012 * T³)) / 3.5
Where T=Time spent on treadmill in minutes
The standard MET calculation which is based on Bayer’s protocol is a passive approach where treadmill is is driving equipment and the subject reacts to the speed of the treadmill. The MET is generally calculated based on fixed amount of time spent on the treadmill.
Compared to this, the Cardiac Risk Assessment test of the present invention applies a technique where the subject drives the stress generating equipment and MET is calculated from calories consumed per minute. Compared to standard treadmill test, Cardiac Risk Assessment technique of the instant invention provides more accurate and reliable MET outcome. Also, the induced stress is regulated by the subject based on fatigue and is not driven through pre defined speed of a treadmill. Thus this is a safer technique compared to the treadmill test as it is self regulated.
Further, as per the data generated from the experiments conducted the sensitivity of the present system ranges from 61% to 73%, as reported by various analysts, and specificity ranges from 59% to 81%, depending on the study or article referenced. Results of correlative studies have been divided with respect to the use of exercise stress testing in patients with 50% or 70% luminal diameter occlusion. That is for Sensitivity: If 100 persons are tested who have a disease, 61 to 73 persons will have this test positive. For Specificity: If 100 persons are tested who do not have a disease, 59 to 81 persons will have this test negative.
While the present disclosure has been particularly shown and described with respect to various embodiments thereof, it will be understood by those skilled in the art that the foregoing and other changes in forms and details may be made without departing from the spirit and scope of the present disclosure. It is therefore intended that the present disclosure not be limited to the exact forms and details described and illustrated, but fall within the scope of the appended claims.
Although the invention herein is described with various specific embodiments, it will be obvious for a person skilled in the art to practice the embodiments herein with modifications. However, all such modifications are deemed to be within the scope of the invention. It is also to be understood that the description is intended to cover all of the generic and specific features of the embodiments described herein and all the statements of the scope of the embodiments which as a matter of language might be said to fall there between.

, Claims:We Claim:

1. A portable cardiac risk assessment tool for real time recording and processing of data, wherein the cardiac assessment tool is a combination of a stepper with speed and resistance adjustments, wherein the stepper is connected to a Bluetooth enabled ECG equipment.
2. The portable cadiac risk assessment tool as claimed in claim 1, wherein the stepper has a multifunctional LCD display.
3. The portable cadiac risk assessment tool as claimed in claim 1, wherein the multifunctional LCD display of the stepper tracks the calories burnt and time and repition counts.
4. The portable cadiac risk assessment tool as claimed in claim 1, wherein the stepper has a load capacity of upto 130 kilograms.
5. The portable cadiac risk assessment tool as claimed in claim 1, wherein the ECG equipment records and analyses the data real time.
6. The portable cadiac risk assessment tool as claimed in claim 1, wherein the ECG equipment has real time ECG display.
7. A system for portable cardiac risk assessment, comprising:
bluetooth Cardiotrack ECG machine
portable bluetooth blood pressure monitor
portable stepper with steps and calorie count
connecting to remote doctor through cloud calling to observe the process
generation of consolidated report with ECG signals, heart rate and MET score
8. The system as claimed in claim 7, wherein the raw ECG data is captured and transmission is done from the device to the Cardiotrack Android App
9. The system as claimed in claim 7, wherein the processing of the raw ECG data is done with specific filters to remove signal noise, ECG baseline drift, muscle artifacts, movement artifacts and performing signal correction for clean ECG while the patient is on the stepper.
10. The system as claimed in claim 7, wherein transmitting the running ECG from the device to the app to the cloud to the remote doctor.
11. The system as claimed in claim 7, wherein the analysis is done real time and risk assessment at home is made possible.
12. The system as claimed in claim 7, wherein the heart rate is calculated from the running ECG.