About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Native Pakistani
Men aged 35-60 years & women aged 35-65 years
Willing to consent to participation
Disqualifiers
None
Trial population
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.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
Incidence of diabetes measured by HbA1C
Glycosylated hemoglobin (HbA1C) will be used to assess the incidence of diabetes. HbA1C of greater than or equal to 6.5% will be taken as diabetic
Risk factors of clinical cardiovascular disease
Regression will be done to assess the association of multiple factors like age, gender, family history, medical history etc with cardiovascular disease
Incidence of hypertension in mm Hg measured by Omron digital BP apprataus
Systolic and diastolic blood pressure will be measured in each participant using a DINAMAP monitor (General Electric). Field workers will measure each adult's blood pressure on the right arm while the person will be in a seated position. Blood pressure will be measured twice with at least one minute between measurements. We will use the average of the two blood pressure measurements in our study. Average Bp of greater than 140/90 will be taken as hypertensive.
Sponsors and contacts
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Tabba Heart Institute
Lead sponsor
Getz Pharma
Collaborator