Pakistan Study of Premature Coronary Atherosclerosis in Young Adults
PAKSEHAT
1 other identifier
observational
2,000
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2021
CompletedFirst Posted
Study publicly available on registry
December 14, 2021
CompletedStudy Start
First participant enrolled
March 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2028
April 7, 2023
April 1, 2023
4.9 years
November 30, 2021
April 5, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Burden of atherosclerotic plaque assessed via coronary computed tomography angiography
Burden and progression of atherosclerotic plaque will by measured by coronary computed tomographical angiography (CCTA). Participants will first undergo a non-contrast-enhanced cardiac CT for coronary artery calcium (CAC) scoring, followed by a contrast-enhanced CCTA. Toshiba Aquilion Multislice CT scanners and prospective ECG triggering will be used. Sublingual nitroglycerin will be administered as per standard protocols approximately 3 minutes before the CCTA scan, and intravenous contrast will be injected at a rate of 5.5-7 ml/s depending on the body habitus of the participant; for an average patient, the dose of contrast is expected to be approximately 60-80 mL. The non-contrast-enhanced images will be transferred to the Cardiology CT core lab at Tabba Heart Institute and evaluated by trained radiologists who will quantify CAC according to Agatston's method.
5 years
Secondary Outcomes (3)
Incidence of diabetes measured by HbA1C
5 years
Risk factors of clinical cardiovascular disease
5 years
Incidence of hypertension in mm Hg measured by Omron digital BP apprataus
5 years
Study Arms (1)
Young Pakistanis
Young pakistani population with no history of cardiovascular disease and stroke
Eligibility Criteria
We plan to recruit 2,000 young-to-middle aged adult Pakistani men and women with no known clinical ASCVD. Because the focus of this study is to investigate the prevalence, severity, and determinants of early coronary atherosclerosis in Pakistani adults, we will focus on apparently healthy (i.e., without known clinical CVD) young native Pakistanis. Also, because premature coronary events are more frequent and usually observed at younger ages in men than in women, the age range of male participants at enrollment will be 35-60 years, while this will be 35-65 years for female participants; and enrollment will use a 1:1 male: female ratio.
You may qualify if:
- Native Pakistani
- Men aged 35-60 years \& women aged 35-65 years
- Willing to consent to participation
You may not qualify if:
- eGFR \< 60 ml/min/1.73m2
- Pregnant women
- History of stroke or MI (CABG or PCI)
- History of Peripheral arterial disease
- Weight more than 102 Kg
- Any active malignancy
- Known contraindication from contrast used in cardiac CTA
- Expected migration from residential area within 5 years
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tabba Heart Institutelead
- Getz Pharmacollaborator
Study Sites (1)
Tabba Heart Institute
Karachi, Sindh, 74500, Pakistan
Related Publications (1)
Hanif B, Sheikh S, Peerwani G, Cainzos-Achirica M, Javed W, Baqar JB, Samad Z, Bashir F, S Virani S, Nasir K, Aijaz S. PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT): a prospective longitudinal study protocol investigating the prevalence, severity and determinants of atherosclerotic cardiovascular disease in the young adult Pakistani population. BMJ Open. 2023 Nov 19;13(11):e076045. doi: 10.1136/bmjopen-2023-076045.
PMID: 37984941DERIVED
Biospecimen
Approximately 10 ml of blood will be stored for at least 10 years.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2021
First Posted
December 14, 2021
Study Start
March 15, 2023
Primary Completion (Estimated)
February 1, 2028
Study Completion (Estimated)
November 1, 2028
Last Updated
April 7, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share