NCT05156736Recruiting
Pakistan Study of Premature Coronary Atherosclerosis in Young Adults
Pakistan Study of Premature Coronary Atherosclerosis in Young Adults (PAK SEHAT)
Source: ClinicalTrials.gov · Last updated 7 Apr 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Coronary heart disease (CHD) is a major cause of morbidity, disability, mortality, and health expenditures worldwide. A wealth of studies has demonstrated that people of South Asian ancestry have a higher risk of CHD and particularly premature CHD than most other racial/ethnic groups, and recent research suggests that this risk is higher in Pakistanis than in Indians-the two largest SA groups. Pakistan is the 5th most populous country in the world, and despite these concerning trends, so far there has been a scarcity of large studies evaluating the prevalence of cardiovascular risk factors and subclinical coronary atherosclerosis in young-to-middle-aged Pakistanis. Also, there is currently no cardiovascular risk score specifically tailored to younger Pakistani men and women. The PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT) aims at addressing these important gaps. PAK-SEHAT is an ongoing prospective cohort study that will enroll 2,000 asymptomatic Pakistani men aged 35 to 60 years and women aged 35 to 65 years from the general population, free of clinically overt cardiovascular disease. Participants will undergo a comprehensive baseline exam including coronary computed tomography angiography, and will be followed for incident events and repeat testing for 5 years. PAK-SEHAT will allow determining the prevalence, severity, determinants, and prognostic significance of early atherosclerosis in apparently healthy young-to-middle-aged Pakistanis. This knowledge can help inform primordial and primary prevention strategies, enhanced cardiovascular risk stratification, and potential plaque-screening approaches in Pakistan, all of which can ultimately help reduce the burden of CHD in the country. In this report investigators describe the rationale, objectives, methods, and discuss the potential implications of the PAK-SEHAT study.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 2000 (estimated)
- First submitted
- 30 Nov 2021
- Start date
- 15 Mar 2023
- Primary completion date
- Feb 2028
- Lead sponsor
- Tabba Heart Institute
- NCT number
- NCT05156736
What you commit to
- Study type: Observational
- Planned participants: 2000
- From 15 Mar 2023 to the primary completion date, Feb 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of stroke or MI (CABG or PCI)
- History of Peripheral arterial disease
- Any active malignancy
- Known contraindication from contrast used in cardiac CTA
Lab values
- eGFR \< 60 ml/min/1.73m2
Other
- Pregnant women
- Weight more than 102 Kg
- Expected migration from residential area within 5 years
Who the study is looking for
- Native Pakistani
- Men aged 35-60 years \& women aged 35-65 years
- Willing to consent to participation
Age in the registry: 35 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Tabba Heart Institute Coordinator of this site? Confirm its status | Karachi | Pakistan | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.