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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
  1. Bashir Hanif1,
  2. Sana Sheikh2,
  3. Ghazal Peerwani2,
  4. Miguel Cainzos-Achirica3,4,
  5. Wajiha Javed5,
  6. Jaffer Bin Baqar5,
  7. Zainab Samad6,
  8. Faiza Bashir7,
  9. Salim S Virani8,9,
  10. Khurram Nasir10,11,
  11. Saba Aijaz12
  1. 1Department of Cardiology, Tabba Heart Institute, Karachi, Sindh, Pakistan
  2. 2Clinical Research Cardiology, Tabba Heart Institute, Karachi, Pakistan
  3. 3Department of Cardiology, Hospital del Mar, Barcelona, Spain
  4. 4Department of Cardiology, Institut Hospital del Mar d'Investigacions Mediques, Barcelona, Spain
  5. 5Department of Public Health, Getz Pharma, Karachi, Pakistan
  6. 6Medicine, The Aga Khan University, Karachi, Pakistan
  7. 7Department of Medicine, Ziauddin Medical University, Karachi, Pakistan
  8. 8Department of Medicine, The Aga Khan University Hospital, Karachi, Pakistan
  9. 9Department of Medicine, Texas Heart Institute, Houston, Texas, USA
  10. 10Department of Medicine, Houston Methodist, Houston, Texas, USA
  11. 11Department of Medicine, Johns Hopkins Medical Institutions Campus, Baltimore, Maryland, USA
  12. 12Cardiology, Clinical Research Cardiology, Tabba Heart Institute, Karachi, Pakistan
  1. Correspondence to Dr Bashir Hanif; bhanif{at}yahoo.com

Abstract

Introduction 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.

Methods and analysis 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.

Ethics and dissemination 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.

Trial registration number NCT05156736.

  • Cardiac Epidemiology
  • Coronary heart disease
  • Myocardial infarction
  • Adult cardiology
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Footnotes

  • Contributors BH—conceptualisation, funding acquisition, methodology, supervision and editing and reviewing the manuscript. SS—curating methodology, writing initial draft and editing and reviewing the manuscript. GP—curating methodology, writing initial draft and editing and reviewing the manuscript. MC-A—methodology, visualisation, writing initial draft and editing and reviewing the manuscript. WJ—funding acquisition, methodology, supervision and editing and reviewing the manuscript. JBB—methodology and editing and reviewing the manuscript. ZS—methodology and editing and reviewing the manuscript. FB—editing and reviewing the manuscript. SSV—curating methodology, writing initial draft and editing and reviewing the manuscript. KN—curating methodology and editing and reviewing the manuscript. SA—curating methodology, writing initial draft and editing and reviewing the manuscript. All authors approved the manuscript and this submission. SS and GP share the second authorship as per their contribution.

  • Funding This study is funded by our study partner Getz Pharma Private Limited (study registration number: GPPL-PH-002).

  • Map disclaimer The inclusion of any map (including the depiction of any boundaries therein), or of any geographic or locational reference, does not imply the expression of any opinion whatsoever on the part of BMJ concerning the legal status of any country, territory, jurisdiction or area or of its authorities. Any such expression remains solely that of the relevant source and is not endorsed by BMJ. Maps are provided without any warranty of any kind, either express or implied.

  • Competing interests WJ is the head of public health and JBB is a senior manager at Getz Pharma Private Limited.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.