Clinical trial NCT04903041: A Cardiac Registry to Evaluate and Manage the hsTnI Categorical CVD Risk in Subjects Undergoing Preventive Health Checks (PHC).
Official title: A Cardiac Registry to Evaluate and Manage the hsTnI Categorical CVD Risk in Subjects Undergoing Preventive Health Checks (PHC).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Lead sponsor: Abbott Diagnostics Division
Sponsor class: INDUSTRY
Collaborators: name: Apollo Hospitals Enterprise Limited
First posted: 2021-05-26
Enrollment: 300000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Evaluate the hsTnI categorical CVD risk model with the Apollo Healthcare system in subjects attending the Preventive Health Checkups.
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Implementation of recommendation for the low, moderate and high risk in subjects and monitoring the outcome in the cardiac registry database.
timeFrame: Through study completion, an average of 1 year
Other outcomes:
measure: Optimize the use of hsTnI risk categories by clinicians
timeFrame: Through study completion, an average of 1 year
Locations:
city: Bangalore
country: India
facility: Apollo Hospitals
city: Chennai
country: India
facility: Apollo Hospitals
city: Hyderabad
country: India
facility: Apollo Hospitals
city: Kolkata
country: India
facility: Apollo Hospitals
city: Mumbai
country: India
facility: Apollo Hospitals
city: New Delhi
country: India
facility: Apollo Hospitals
Study officials:
affiliation: Apollo Hopsitals
name: Pratap C Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Hospitals Enterprise Limited
name: Hari Prasad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Hospitals Enterprise Limited
name: Abraham Oomman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Apollo Hospitals Enterprise Limited
name: Padma Madala, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott
name: Jaganathan Sickan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Abbott
name: Agim Beshiri, MD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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citation: 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.