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

NCT04903041 | Suspended

• 1 other identifier: ACCR
• Study Type: observational
• Target: 300,000
• Locations: 1 country
• Sites: 6

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.

Conditions

Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Other Outcomes (1)

• Optimize the use of hsTnI risk categories by clinicians

  Through study completion, an average of 1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All subjects undergoing health checks at Apollo Group of hospitals in Hyderabad, Chennai, Bangalore, Mumbai, Kolkata and New Delhi.

You may qualify if:

• All men and women above the age of 18 years
• Lipid profiles ordered
• HbA1c ordered
• Creatinine ordered

You may not qualify if:

• \. Non-consenting subjects

Sponsors & Collaborators

• Jaime Marino: lead
• Apollo Hospitals Enterprise Limited: collaborator

Study Sites (6)

Apollo Hospitals

Bangalore, India

Location

Apollo Hospitals

Chennai, India

Location

Apollo Hospitals

Hyderabad, India

Location

Apollo Hospitals

Kolkata, India

Location

Apollo Hospitals

Mumbai, India

Location

Apollo Hospitals

New Delhi, India

Location

Related Publications (8)

• Lankeit M, Jimenez 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.

  PMID: 22082681 BACKGROUND

• 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.

  PMID: 21149316 BACKGROUND

• Rosjo H, Varpula M, Hagve TA, Karlsson S, Ruokonen E, Pettila 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.

  PMID: 20938765 BACKGROUND

• 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.

  PMID: 21806764 BACKGROUND

• Hoiseth AD, Neukamm A, Karlsson BD, Omland T, Brekke PH, Soyseth 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.

  PMID: 21653926 BACKGROUND

• 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.

  PMID: 21139111 BACKGROUND

• 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.

  PMID: 21078811 BACKGROUND

• Meune C, Reichlin T, Irfan A, Schaub N, Twerenbold R, Meissner J, Reiter M, Luthi 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.

  PMID: 22410086 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

• Pratap C Reddy, MD

  Apollo Hopsitals

  PRINCIPAL INVESTIGATOR

• Hari Prasad, MD

  Apollo Hospitals Enterprise Limited

  PRINCIPAL INVESTIGATOR

• Abraham Oomman, MD

  Apollo Hospitals Enterprise Limited

  PRINCIPAL INVESTIGATOR

• Padma Madala, MD

  Apollo Hospitals Enterprise Limited

  PRINCIPAL INVESTIGATOR

• Jaganathan Sickan, MD

  Abbott

  PRINCIPAL INVESTIGATOR

• Agim Beshiri, MD

  Abbott

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sr Medical Affairs Manager

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 26, 2021
• Study Start: September 12, 2019
• Primary Completion (Estimated): September 12, 2029
• Study Completion (Estimated): September 12, 2030
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IN (6)