Department of Cardiology, Tabba Heart Institute, Karachi, Sindh, Pakistan
Clinical Research Cardiology, Tabba Heart Institute, Karachi, Pakistan.
BMJ Open. 2023 Nov 19;13(11):e076045. doi: 10.1136/bmjopen-2023-076045.
Atherosclerotic cardiovascular disease (ASCVD) is a major cause of morbidity, mortality and health expenditures worldwide. Despite having higher ASCVD in the Pakistani population, data on subclinical coronary atherosclerosis in young Pakistanis remain scarce. The PAKistan Study of prEmature coronary atHerosclerosis in young AdulTs (PAK-SEHAT) aims to assess the prevalence, severity and determinants of subclinical coronary atherosclerosis among Pakistani men (35-60 years) and women (35-65 years) free of clinically symptomatic ASCVD and will assess 5-year rates of ASCVD events.
PAK-SEHAT is an ongoing prospective cohort study with 2000 participants from all provinces of Pakistan who will be interviewed at the baseline along with phlebotomy, measurement of carotid intima-media thickness (CIMT) and coronary CT angiography (CCTA). Phlebotomy will be repeated at 2.5 years, whereas CIMT and CCTA will be repeated at 5 years. We will report the frequency of maximal coronary stenosis ≥50% and ≥70%, number of coronary vessels with plaque and the number of coronary segments affected per participant on CCTA. We will use Cox proportional hazards regression models to evaluate the association between baseline characteristics and incident ASCVD events during follow-up. These associations will be presented as HRs with 95% CIs.
The study protocol was approved by the Tabba Heart Institute Institutional Review Board (THI/IRB/FQ/22-09-2021/016). All study procedures are consistent with the principles of the Declaration of Helsinki. Findings of the study will be disseminated via peer-reviewed publications and conference presentations.
NCT05156736.
动脉粥样硬化性心血管疾病(ASCVD)是全球发病率、死亡率和卫生支出的主要原因。尽管巴基斯坦人口的 ASCVD 发病率更高,但有关年轻巴基斯坦人亚临床冠状动脉粥样硬化的数据仍然很少。PAKistan 研究青年成人过早冠状动脉粥样硬化(PAK-SEHAT)旨在评估无临床症状 ASCVD 的年轻巴基斯坦男性(35-60 岁)和女性(35-65 岁)中亚临床冠状动脉粥样硬化的流行率、严重程度和决定因素,并将评估 5 年 ASCVD 事件发生率。
PAK-SEHAT 是一项正在进行的前瞻性队列研究,共有来自巴基斯坦所有省份的 2000 名参与者,他们将在基线时接受访谈,同时进行静脉采血、颈动脉内膜中层厚度(CIMT)和冠状动脉 CT 血管造影(CCTA)测量。静脉采血将在 2.5 年后重复,而 CIMT 和 CCTA 将在 5 年后重复。我们将报告最大冠状动脉狭窄≥50%和≥70%的频率、斑块存在的冠状动脉血管数量以及每个参与者受影响的冠状动脉节段数量。我们将使用 Cox 比例风险回归模型评估基线特征与随访期间发生 ASCVD 事件之间的关联。这些关联将以 HRs 及其 95%CI 表示。
该研究方案已获得 Tabba 心脏研究所机构审查委员会(THI/IRB/FQ/22-09-2021/016)的批准。所有研究程序均符合《赫尔辛基宣言》的原则。研究结果将通过同行评议的出版物和会议报告进行传播。
NCT05156736。