Registry to evaluate cardiac risk using high-sensitivity troponin I in preventive health checks
A Cardiac Registry to Evaluate and Manage the hsTnI Categorical CVD Risk in Subjects Undergoing Preventive Health Checks (PHC).
This study is testing if a new blood test for a heart protein can help find people at risk for heart disease during routine health checks, even if they don't have typical risk factors.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Abbott Diagnostics Division Industry-sponsored |
| Locations | 6 sites (Bangalore and 5 other locations) |
| Trial ID | NCT04903041 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess cardiovascular disease (CVD) risk in individuals undergoing preventive health checks by utilizing high-sensitivity assays for cardiac troponin I (hs-TnI). The study focuses on identifying individuals at risk for CVD who may not show traditional risk factors, thereby enhancing early detection and management. By measuring hs-TnI levels, the study seeks to improve risk stratification and inform clinical decisions regarding preventive measures. The findings could lead to better-targeted interventions for those at risk of developing cardiovascular conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are men and women over the age of 18 who are undergoing preventive health checks and have lipid profiles, HbA1c, and creatinine tests ordered.
Not a fit: Patients who do not consent to participate in the study will not benefit from its findings.
Why it matters
Potential benefit: If successful, this study could provide a more accurate method for identifying individuals at risk of cardiovascular diseases, leading to timely interventions.
How similar studies have performed: Other studies have shown promise in using high-sensitivity troponin assays for risk stratification, indicating that this approach is supported by prior research.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bangalore and 5 other locations
- Apollo Hospitals — Bangalore, India (Recruiting)
- Apollo Hospitals — Chennai, India (Recruiting)
- Apollo Hospitals — Hyderabad, India (Recruiting)
- Apollo Hospitals — Kolkata, India (Recruiting)
- Apollo Hospitals — Mumbai, India (Recruiting)
- Apollo Hospitals — New Delhi, India (Recruiting)
Study contacts
- Principal investigator: Pratap C Reddy, MD — Apollo Hopsitals
- Study coordinator: S Danalakshmi, MD
- Email: info_kkd@apollohospitals.com
- Phone: 91 - 0884 - 2302600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.