A Cardiac Registry to Evaluate and Manage the hsTnI Categorical CVD Risk in Subjects Undergoing Preventive Health Checks (PHC).

Cardiovascular Diseases Clinical Trial

Official title:

A Cardiac Registry to Evaluate and Manage the hsTnI Categorical CVD Risk in Subjects Undergoing Preventive Health Checks (PHC).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04903041
• Other study ID #: ACCR
• Status: Recruiting
• Start date: September 12, 2019
• Est. completion date: September 12, 2030

Study information

• Verified date: August 2022
• Source: Abbott Diagnostics Division
• Contact: S Danalakshmi, MD
• Phone: 91 - 0884 - 2302600
• Email: info_kkd[@]apollohospitals.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Cardiovascular disease is the leading cause of mortality globally. In India cardiovascular disease leads to death a decade earlier than in western countries. In the past 20 years awareness and classic risk factors and statins have been the main improvements. However, all these factors have not decreased the cardiovascular disease burden. One reason may be because all of the current assessments for cardiac risk are correlants to disease and none are specific to cardiac myocyte status.

Description:

Development of high-sensitivity assays for cardiac troponin I (hs-TnI) has enhanced the ability to detect low circulating levels of cardiac troponins, which are often present in individuals with common cardiac conditions and risk factors who have not manifested clinical cardiovascular disease (CVD). Lowering the detection threshold of troponin assays has expanded the potential use of cardiac troponins from a diagnostic tool in the setting of acute coronary syndrome to a biomarker for risk stratification in individuals without known CVD. Detectable levels of cardiac troponins have been associated with increased incidence of coronary heart disease (CHD), heart failure (HF), and cardiovascular mortality in community-based studies.

Traditional cardiovascular risk prediction does not identify everyone who will develop cardiovascular disease with up to 50% of individuals having none or only one risk factor at the time of diagnosis. Although traditional risk estimations perform moderately well, there remain significant limitations in their use in the prevention of cardiovascular disease especially at an individual level. At an individual level, the clinician not only needs to correctly identify those at increased risk, but also weigh up the importance of each risk factor and determine who needs medical therapy in addition to lifestyle advice Many risk estimation systems in existence are based on a core set of cardiovascular risk factors and based on participants either selected randomly from the general population or those attending their general practitioner. All these risk scoring systems show a good level of discrimination, for cardiovascular events, with the area under the receiving operator curve ranging from 0.73 to 0.82. However, adopting these risk scoring systems to guide current clinical practice has limitations. First, most of these scoring systems, except QRISK1 and QRISK2 have been developed from old prospective cohorts with participants recruited in the 1980's and 1990's Second, applying risk estimation scores to regions with different rates of baseline rates of cardiovascular disease will lead to either under- or over-estimation of risk: a result of mis-calibration. Third, the value of incorporating new risk factors including biomarkers such as high-sensitivity C reactive protein has been disappointing in improving discrimination, with age and sex alone contributing to 0.70 of the area under the receiver operating curve statistic. None of these risk estimation scores, to date, incorporate a direct measure of cardiac injury such as cardiac troponin and its potential role in guiding primary prevention in a contemporaneous population remains uncertain.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300000
• Est. completion date: September 12, 2030
• Est. primary completion date: September 12, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. All men and women above the age of 18 years

2. Lipid profiles ordered

3. HbA1c ordered

4. Creatinine ordered

Exclusion Criteria:

1. Non-consenting subjects

Related Conditions & MeSH terms

• Cardiovascular Diseases

Locations

Country	Name	City	State
India	Apollo Hospitals	Bangalore
India	Apollo Hospitals	Chennai
India	Apollo Hospitals	Hyderabad
India	Apollo Hospitals	Kolkata
India	Apollo Hospitals	Mumbai
India	Apollo Hospitals	New Delhi

Sponsors (2)

Lead Sponsor	Collaborator
Jaime Marino	Apollo Hospitals Enterprise Limited

Country where clinical trial is conducted

India, 

References & Publications (8)

Afonso L, Bandaru H, Rathod A, Badheka A, Ali Kizilbash M, Zmily H, Jacobsen G, Chattahi J, Mohamad T, Koneru J, Flack J, Weaver WD. Prevalence, determinants, and clinical significance of cardiac troponin-I elevation in individuals admitted for a hypertensive emergency. J Clin Hypertens (Greenwich). 2011 Aug;13(8):551-6. doi: 10.1111/j.1751-7176.2011.00476.x. Epub 2011 Jun 27. — View Citation

de Lemos JA, Drazner MH, Omland T, Ayers CR, Khera A, Rohatgi A, Hashim I, Berry JD, Das SR, Morrow DA, McGuire DK. Association of troponin T detected with a highly sensitive assay and cardiac structure and mortality risk in the general population. JAMA. 2010 Dec 8;304(22):2503-12. doi: 10.1001/jama.2010.1768. Erratum in: JAMA. 2011 Mar 23;305(12):1200. — View Citation

deFilippi CR, de Lemos JA, Christenson RH, Gottdiener JS, Kop WJ, Zhan M, Seliger SL. Association of serial measures of cardiac troponin T using a sensitive assay with incident heart failure and cardiovascular mortality in older adults. JAMA. 2010 Dec 8;304(22):2494-502. doi: 10.1001/jama.2010.1708. Epub 2010 Nov 15. — View Citation

Høiseth AD, Neukamm A, Karlsson BD, Omland T, Brekke PH, Søyseth V. Elevated high-sensitivity cardiac troponin T is associated with increased mortality after acute exacerbation of chronic obstructive pulmonary disease. Thorax. 2011 Sep;66(9):775-81. doi: 10.1136/thx.2010.153122. Epub 2011 Jun 8. — View Citation

Lankeit M, Jiménez D, Kostrubiec M, Dellas C, Hasenfuss G, Pruszczyk P, Konstantinides S. Predictive value of the high-sensitivity troponin T assay and the simplified Pulmonary Embolism Severity Index in hemodynamically stable patients with acute pulmonary embolism: a prospective validation study. Circulation. 2011 Dec 13;124(24):2716-24. doi: 10.1161/CIRCULATIONAHA.111.051177. Epub 2011 Nov 14. — View Citation

Meune C, Reichlin T, Irfan A, Schaub N, Twerenbold R, Meissner J, Reiter M, Lüthi A, Haaf P, Balmelli C, Drexler B, Winkler K, Hochholzer W, Osswald S, Mueller C. How safe is the outpatient management of patients with acute chest pain and mildly increased cardiac troponin concentrations? Clin Chem. 2012 May;58(5):916-24. doi: 10.1373/clinchem.2011.178053. Epub 2012 Mar 12. — View Citation

Røsjø H, Varpula M, Hagve TA, Karlsson S, Ruokonen E, Pettilä V, Omland T; FINNSEPSIS Study Group. Circulating high sensitivity troponin T in severe sepsis and septic shock: distribution, associated factors, and relation to outcome. Intensive Care Med. 2011 Jan;37(1):77-85. doi: 10.1007/s00134-010-2051-x. Epub 2010 Oct 12. — View Citation

Xue Y, Clopton P, Peacock WF, Maisel AS. Serial changes in high-sensitive troponin I predict outcome in patients with decompensated heart failure. Eur J Heart Fail. 2011 Jan;13(1):37-42. doi: 10.1093/eurjhf/hfq210. Epub 2010 Dec 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Optimize the use of hsTnI risk categories by clinicians	Estimate the longitudinal changes of the number of clinicians that recommend the following based on the cardiovascular risk stratification algorithm: lifestyle consultation, treatment of underlying conditions such as hypertension, diabetes, hyperlipidemia as well as ECG, stress test and echocardiography recommendations.	Through study completion, an average of 1 year
Primary	Evaluate the hsTnI categorical CVD risk model with the Apollo Healthcare system in subjects attending the Preventive Health Checkups.	Number of individuals classified as high, moderate, low risk based on the pre-defined cut-offs of high-sensitivity troponin I.	Through study completion, an average of 1 year
Secondary	Implementation of recommendation for the low, moderate and high risk in subjects and monitoring the outcome in the cardiac registry database.	Number of individuals that follows the cardiovascular risk stratification algorithm: lifestyle consultation, treatment of underlying conditions such as hypertension, diabetes, hyperlipidemia as well as ECG, stress test echocardiography recommendations and number of individuals experiencing the adverse cardiovascular outcomes per cardiovascular risk category.	Through study completion, an average of 1 year