Pakistan Study of Premature Coronary Atherosclerosis in Young Adults (PAK SEHAT)

Study Objectives The primary objectives of PAK-SEHAT are: 1) characterize the prevalence and severity of subclinical coronary atherosclerosis among young-to-middle aged Pakistani men and women free of clinical CVD, and 2) assess 5-year rates of ASCVD events. The secondary objectives of the study are to 1) determine the prevalence of diabetes, hypertension, dyslipidemia, and other cardiovascular risk factors among young Pakistani men and women free of clinical CVD; 2) identify the determinants of subclinical coronary atherosclerosis in this population; 3) estimate the incidence of diabetes, hypertension, dyslipidemia, and other cardiovascular risk factors at 5 years of follow-up; 4) identify independent risk factors and markers of incident clinical ASCVD among young asymptomatic Pakistanis.

Study Design PAK-SEHAT is a prospective cohort study, with a target study population of 2,000 participants and a planned prospective follow-up of 5 years after study enrollment.

Study Population Investigators 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, focus will be on apparently healthy (i.e., without known clinical CVD) young-to-middle 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.

Sampling Strategy: PAK-SEHAT aims to be as representative as possible of the general Pakistani population, and a multi-stage cluster sampling strategy will be used to identify candidates to participate in the study. The first stage of the sampling process occurs at the province level, which is the largest administrative division in the country, and participants will be recruited from all four Pakistani provinces and the Federal territory of Islamabad. A cluster is defined as the selected tertiary care hospital offering clinical cardiac services. The selection criteria of hospital include clinical cardiac services being provided and availability of CT coronary angiogram. Next, cities are selected, and within those, the hospitals. The distribution of the sample across the provinces was done proportionate to the size sampling method. We are collaborating with eight hospital sites across the country to achieve our sample size. Tabba Heart Institute Karachi, Safari Hospital Rawalpindi, Bahria international Hospital Lahore, Doctors Hospital and medical center Lahore, Faisalabad Institute of Cardiology, Medikay Cardiac Center Islamabad, Peshawar Institute of Cardiology and Tabba Heart Institute Quetta.

Participant Enrollment The attendant of the patients admitted to the hospital will be offered to participate in the study. The volunteers for the study will be recruited through advertisement of the study using pamphlets, posters, electronic medium such as FM radio and digital platforms such as facebook, twitter, and instagram. Individuals who are deemed eligible to participate in the study will be provided with detailed information about the study, invited to ask questions, and asked to provide written informed consent for participation.