Cardiohealth Methods and Apparatus

• US 20120065514A1
• Filed: 12/25/2009
• Published: 03/15/2012
• Est. Priority Date: 12/30/2008
• Status: Abandoned Application

• Current Assignee: Endothelix Co.
• Original Assignee: Endothelix Co.
• Inventors: Naghavi, Morteza, Yen, Albert Andrew, Hassan, Haider Ali, Panthagani, David S., Hecht, Harvey S.
• Application Number:
  US13/142,548
• Publication Number:
  US 20120065514A1
• Time in Patent Office: Days
• US Class Current: 600/454
• CPC Class Codes: A61B 2560/0431 Portable apparatus, e.g. comprising a handle or case
• CPC Class Codes: A61B 2560/0437 Trolley or cart-type apparatus
• CPC Class Codes: A61B 2562/0271 Thermal or temperature sensors
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• CPC Class Codes: A61B 5/02055 Simultaneously evaluating both cardiovascular condition and temperature
• CPC Class Codes: A61B 5/02125 of pulse wave propagation time
• CPC Class Codes: A61B 5/022 by applying pressure to close blood vessels, e.g. against the skin; Ophthalmodynamometers
• CPC Class Codes: A61B 5/0537 Measuring body composition by impedance, e.g. tissue hydration or fat content
• CPC Class Codes: A61B 5/14546 for measuring analytes not otherwise provided for, e.g. ions, cytochromes
• CPC Class Codes: A61B 5/1455 using optical sensors, e.g. spectral photometrical oximeters
• CPC Class Codes: A61B 5/318 Heart-related electrical modalities, e.g. electrocardiography [ECG]
• CPC Class Codes: A61B 5/6824 Arm or wrist
• CPC Class Codes: A61B 5/6826 Finger
• CPC Class Codes: A61B 5/6838 Clamps or clips
• CPC Class Codes: A61B 5/6841 by using templates
• CPC Class Codes: A61B 5/7275 Determining trends in physiological measurement data; Predicting development of a medical condition based on physiological measurements, e.g. determining a risk factor
• CPC Class Codes: G01K 13/20 Clinical contact thermometers for use with humans or animals
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 50/30 for calculating health indices; for individual health risk assessment

Abstract

Methods and apparatus for improving measurements of cardiovascular health status in a given individual are provided. The comprehensive assessment of cardiovascular health includes at least two components: risk factor assessment based on epidemiologic studies and functional status of the individual. Structural studies of the individual can also be included in the comprehensive assessment of cardiovascular health. The invention aims to improve detection, treatment, devices, and administration of cardiovascular risk assessment.

Claims

1. A method for assessment of cardiovascular health, comprising:

calculating a risk score based on risk factors,

measuring an indicator of cardiovascular function,

measuring an indicator of cardiovascular structure, and

combining the risk score, indicator of cardiovascular function, and indicator of cardiovascular structure to provide a comprehensive assessment of cardiovascular health.

2. The method of claim 1 wherein the risk score is selected from the group consisting of Framingham Risk Scoring (FRS), Diabetes Mellitus risk scoring (DM), Metabolic Syndrome (MS) Risk Scoring, Adult Treatment Panel III (ATP III), Prospective Cardiovascular Munster Heart Study (PROCAM), Systematic Coronary Risk Evaluation (SCORE), United Kingdom Prospective Diabetes Study (UKPDS), Reynolds Risk Score, Homeostasis Model Assessment (HOMA), European Society of Cardiology, European Society of Atherosclerosis, European Society of Hypertension, British Regional Heart Study, Sheffield Coronary Risk Tables, General Rule to Enable Atheroma Treatment (GREAT), Dundee Coronary Risk-Disk, National Heart Foundation of New Zealand Guidelines, West of Scotland Cardiovascular Event Reduction Tool, Joint British Recommendations on Prevention of Coronary Heart Disease in Clinical Practice, or combinations thereof.

3. The method of claim 1 wherein the indicator of cardiovascular function is determined subsequent to vascular challenge by a test selected from the group consisting of:

Blood Pressure (BP), Pulse Wave Velocity (PWV), Pulse Wave Flow (PWF), Doppler Flow Velocity (DFV), Digital Thermal Monitoring (DTM), contralateral vascular reactivity (CLVR), serological assays of endothelial progenitor cells (EPC), and/or combinations thereof.

4. The method of claim 1 wherein the indicator of cardiovascular function is from fluid tests or measurements selected from the group consisting of:

total cholesterol, HDL, LDL, triglycerides, blood thrombogenicity or clotting, insulin, hemoglobin A1c, liver enzymes, lipid panels, natriuretic factors, CRP, or combinations thereof.

5. The method of claim 1, wherein the indicator of cardiovascular structure is a measure of pathologic changes of intima medial thickness, atherosclerotic plaque formation, calcium deposits in at least one vascular bed, or combinations thereof.

6. The method of claim 1, wherein the indicator of cardiovascular structure is measured by the group consisting of:

BP, ABI, toe brachial index (TBI), toe finger index (TFI), body mass index (BMI), body fat, visceral fat, heart rate variability, electrical impedance, EKG, photoplethysmography (PPG), or combinations thereof.

34. A method of computerized cardiovascular risk assessment, monitoring, and management for individuals between 25 and 75 years of age that determines an individual'"'"'s cardiovascular risk based on the method described in claim 1 and described in section [0025];

and suggests monitoring and therapeutic management for risk reduction based on the individual'"'"'s age and level of risk, as described in section [0025—

CardioHealth Algorithm].

7. A method for generating a combined relative risk of underlying vascular disease comprising:

entering results of risk factor scoring of an individual into a computational dataset,

performing functional assessments on the individual and obtaining and entering values from the functional assessments into the computational dataset for the individual,

performing structural tests on the individual and obtaining and entering values from the structural tests into the computational dataset for the individual, and

computing a functional, risk factor, and structural risk factor from the computational dataset to provide a report of combined relative risk of underlying vascular disease for the individual.

8. The method of claim 7, further comprising distinguishing the amount of effective treatment to administer to the individual based on the report to lower the risk of the individual developing a future cardiovascular disorder.

9. The method of claim 7 wherein the risk factor testing and epidemiologic risk factor questioning provides results for a risk scoring model selected from the group consisting of:

Framingham Risk Scoring (FRS), Diabetes Mellitus risk scoring (DM), Metabolic Syndrome (MS) Risk Scoring, Adult Treatment Panel III (ATP III), Prospective Cardiovascular Munster Heart Study (PROCAM), Systematic Coronary Risk Evaluation (SCORE), United Kingdom Prospective Diabetes Study (UKPDS), Reynolds Risk Score, Homeostasis Model Assessment (HOMA), European Society of Cardiology, European Society of Atherosclerosis, European Society of Hypertension, British Regional Heart Study, Sheffield Coronary Risk Tables, General Rule to Enable Atheroma Treatment (GREAT), Dundee Coronary Risk-Disk, National Heart Foundation of New Zealand Guidelines, West of Scotland Cardiovascular Event Reduction Tool, and Joint British Recommendations on Prevention of Coronary Heart Disease in Clinical Practice, or combinations thereof.

10. The method of claim 7 wherein the functional assessments of vascular reactivity are subsequent to vascular challenge and determinations from the group consisting of:

BP, Pulse Wave Velocity (PWV), Pulse Wave Flow (PWF), Doppler Flow Velocity (DFV), Digital Thermal Monitoring (DTM), contralateral vascular reactivity (CLVR), serological assays of endothelial progenitor cells (EPC), or combinations thereof.

11. The method of claim 7 wherein the functional assessments of vascular reactivity are from fluid tests or measurements selected from the group consisting of:

total cholesterol, HDL, LDL, triglycerides, blood thrombogenicity or clotting, insulin, hemoglobin a1c, liver enzymes, lipid panels, natriuretic factors, CRP, or combinations thereof.

12. The method of claim 7, wherein the structural tests can measure pathologic changes of increased intima medial thickness, atherosclerotic plaque formation, calcium deposits in at least one vascular bed, or combinations thereof.

13. The method of claim 7, wherein the structural tests are measures of the group consisting of:

BP, ABI, toe brachial index (TBI), toe finger index (TFI), body mass index (BMI), body fat, visceral fat, heart rate variability, electrical impedance, EKG, photoplethysmography (PPG), or combinations thereof.

14. The method of claim 7 wherein the risk factor testing are tests or measurements selected from the group consisting of:

BP, total cholesterol, HDL, LDL, triglycerides, PWV, PWF, DFV, DTM, blood thrombogenicity or clotting, ABI, toe brachial index (TBI), toe finger index (TFI), insulin, hemoglobin A1c, liver enzymes, body mass index (BMI), body fat, visceral fat, heart rate variability, electrical impedance, EKG, photoplethysmography (PPG), lipid panels, natriuretic factors, CRP, or combinations thereof.

35. A method of computerized cardiovascular risk assessment, monitoring, and management for individuals between 25 and 75 years of age that determines an individual'"'"'s cardiovascular risk based on the methods described in claim 7 and described in section [0025];

and suggests monitoring and therapeutic management for risk reduction based on the individual'"'"'s age and level of risk, as described in section [0025—

CardioHealth Algorithm].

15. A method of assessment of cardiovascular health, comprising:

calculating a risk score based on risk factors,

measuring an indicator of cardiovascular function, and

combining the risk score and indicator of cardiovascular function to provide a comprehensive office-based, non-invasive, non-imaging assessment of cardiovascular health.

16. The method of claim 15 wherein the risk score is selected from the group consisting of Framingham Risk Scoring (FRS), Diabetes Mellitus risk scoring (DM), Metabolic Syndrome (MS) Risk Scoring, Adult Treatment Panel III (ATP III), Prospective Cardiovascular Mü

nster Heart Study (PROCAM), Systematic Coronary Risk Evaluation (SCORE), United Kingdom Prospective Diabetes Study (UKPDS), Reynolds Risk Score, Homeostasis Model Assessment (HOMA), European Society of Cardiology, European Society of Atherosclerosis, European Society of Hypertension, British Regional Heart Study, Sheffield Coronary Risk Tables, General Rule to Enable Atheroma Treatment (GREAT), Dundee Coronary Risk-Disk, National Heart Foundation of New Zealand Guidelines, West of Scotland Cardiovascular Event Reduction Tool, Joint British Recommendations on Prevention of Coronary Heart Disease in Clinical Practice, or combinations thereof.

17. The method of claim 15 wherein the risk factors that are used to calculate the risk score are selected from the group consisting of lipid-related risk factors, such as those measured by VAP advanced lipid analysis (offered by Atherotech, Inc.), and inflammation-related risk factors, such as hs-CRP (an indicator of systemic inflammation), Lp-PLA2 (an indicator plaque inflammation;

offered by diaDexus, Inc.), and myeloperoxidase (MPO, offered by PrognostiX, Inc.).

18. The method of claim 15 wherein the indicator of cardiovascular function is determined subsequent to vascular challenge by a test from the group consisting of:

Blood Pressure (BP), Pulse Wave Velocity (PWV), Pulse Wave Flow (PWF), Doppler Flow Velocity (DFV), Digital Thermal Monitoring (DTM), contralateral vascular reactivity (CLVR), pre- and post-exercise Ankle Brachial Index (ABI), pre- and post-exercise serological assays of endothelial progenitor cells (EPC), or combinations thereof.

19. The method of claim 15 wherein the indicator of cardiovascular function is from fluid tests or measurements selected from the group consisting of:

total cholesterol, HDL, LDL, triglycerides, blood thrombogenicity or clotting, insulin, hemoglobin A1c, liver enzymes, lipid panels, natriuretic factors, CRP, or combinations thereof.

24. The apparatus of claim 15 wherein the fluid testing module is capable of tests or measurements selected from the group consisting of:

total cholesterol, HDL, LDL, triglycerides, blood thrombogenicity or clotting, insulin, hemoglobin A1c, liver enzymes, lipid panels, natriuretic factors, CRP, serological assays of endothelial progenitor cells (EPC), or combinations thereof.

25. The apparatus of claim 15 wherein the plurality of testing modules are capable of providing data for risk factor computations that can be adapted for the group consisting of:

Framingham Risk Scoring (FRS), Diabetes Mellitus risk scoring (DM), Metabolic Syndrome (MS) Risk Scoring, Adult Treatment Panel III (ATP III), Prospective Cardiovascular Munster Heart Study (PROCAM), Systematic Coronary Risk Evaluation (SCORE), United Kingdom Prospective Diabetes Study (UKPDS), Reynolds Risk Score, Homeostasis Model Assessment (HOMA), European Society of Cardiology, European Society of Atherosclerosis, European Society of Hypertension, British Regional Heart Study, Sheffield Coronary Risk Tables, General Rule to Enable Atheroma Treatment (GREAT), Dundee Coronary Risk-Disk, National Heart Foundation of New Zealand Guidelines, West of Scotland Cardiovascular Event Reduction Tool, and Joint British Recommendations on Prevention of Coronary Heart Disease in Clinical Practice, or combinations thereof.

26. The apparatus of claim 15 wherein the cardiovascular function module is capable of measurements from the group consisting of:

BP, Pulse Wave Velocity (PWV), Pulse Wave Flow (PWF), Doppler Flow Velocity (DFV), Digital Thermal Monitoring (DTM), contralateral vascular reactivity (CLVR), serological assays of endothelial progenitor cells (EPC), or combinations thereof.

27. The apparatus of claim 15, wherein the electrical communication is controlled by specialized software that computes results from the plurality of testing modules to provide a combined relative risk of underlying vascular disease for the individual.

28. The apparatus of claim 15, further comprising components consisting of:

a pneumatic cuff, a blood testing interface, a temperature probe, a flow sensor, a smart Doppler sensor, ultrasound imaging, an EKG, an electrical impedance measure, a BMI measure, or combinations thereof.

29. The apparatus of claim 15 further comprising a Doppler module to receive data from one or more Doppler probes in order to measure ABI, TBI, TFI, PWV, PWF, and/or DFW.

30. The apparatus of claim 15 wherein the apparatus provides a challenge to facilitate baseline and post-challenge testing.

31. The apparatus of claim 15 wherein the plurality of testing modules are capable of delivering data to a remote destination.

32. The apparatus of claim 15 wherein the apparatus distinguishes the amount of effective treatment to lower the risk of a human developing a future cardiovascular disorder.

33. The apparatus of claim 15 wherein the apparatus enhances compliance of existing drug regimens.

36. A method of computerized cardiovascular risk assessment, monitoring, and management for individuals between 25 and 75 years of age that determines an individual'"'"'s cardiovascular risk based on the methods described in claim 15 and described in section [0025];

and suggests monitoring and therapeutic management for risk reduction based on the individual'"'"'s age and level of risk, as described in section [0025—

CardioHealth Algorithm].

20. (canceled)

21. A method of computerized cardiovascular risk assessment, monitoring, and management according to any one of FIGS. 27-31.

22. A method of computer-assisted management of cardiovascular risk based on lifestyle modifications, including diet, exercise, smoking cessation, nutritional supplements, and over the counter medications, that will enable individuals to self-manage cardiovascular risk reduction.

23. A modular cardiovascular status assessment apparatus, comprising:

a CPU in electrical communication with and controlling a plurality of testing modules including at least a cardiovascular function module, a fluid testing module, and a cardiovascular structure module.