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

Recruiting

• Conditions: Cardiovascular Diseases

• Registration Number: NCT04903041
• Lead Sponsor: Jaime Marino

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2019-09-12
• Study First Submitted: 2021-05-12
• Study First Submitted QC: 2021-05-25
• Study First Posted: 2021-05-26
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-17
• Last Update Posted: 2022-08-19
• Primary Completion: 2029-09-12
• Study Completion: 2030-09-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the hsTnI categorical CVD risk model with the Apollo Healthcare system in subjects attending the Preventive Health Checkups.	Through study completion, an average of 1 year	Number of individuals classified as high, moderate, low risk based on the pre-defined cut-offs of high-sensitivity troponin I.

Secondary Outcome Measures

Name	Time	Method
Implementation of recommendation for the low, moderate and high risk in subjects and monitoring the outcome in the cardiac registry database.	Through study completion, an average of 1 year	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.

Trial Locations

Locations (1)

Apollo Hospitals; 🇮🇳 New Delhi, India