Clinical trial

A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT03892265

Active, not recruitingNot applicableObservational

What this study is about

Investigators will establish a longitudinal cohort of \~3,000 adults \>18 years in Port-au-Prince using multistage random sampling, and follow them longitudinally to evaluate the prevalence and incidence of cardiovascular disease risk factors and diseases. Cardiovascular risk factors include hypertension, diabetes, obesity, dyslipidemia, kidney disease, poor diet, cigarette smoking, physical inactivity, and inflammation. Cardiovascular disease include angina and myocardial infarction, heart failure, stroke, and CVD mortality. It is anticipated that hypertension prevalence will be ≥10% in 18-30 year olds, that hypertension incidence will be \>10 events/1000 person years. Association of determinants and risk factors with CVD will also be examined. Whole blood, serum, plasma, stool, and urine samples will be biobanked for future studies.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed
SexAll
Healthy volunteersNot accepted
ConditionHypertension, Diabetes, Obesity, Kidney Diseases, Dyslipidemias, Smoking, Alcohol Use, Unspecified, Physical Inactivity, Poor Diet, Inflammation, Myocardial Infarction, Heart Failure, Stroke, Cardiac Death

Full registry criteria

Inclusion Criteria: * age \> or = 18 years, primary residence in the study area of Port-au-Prince (defined as having slept at the household at least once in the past two weeks and considers the household their primary residence with no plans to move in the next 24 months), * able to provide consent for study procedures, * agrees to study procedures, and * willing to be contacted at a new residence if a move occurs Exclusion Criteria: * serious medical conditions or cognitive impairment preventing study participation as judged by research physicians, * unable to speak and understand French or Creole.

Treatments and study arms

Observational Study

Other

No intervention is included in this observational study.

Primary outcomes

Prevalence of CVD risk factors and diseases and their association with social and environmental determinants in an established longitudinal cohort of ~3,000 Haitian adultsBaseline

The prevalence of CVD risk factors including HTN, diabetes, obesity, cigarette smoking, dyslipidemia, kidney disease, poor diet, physical inactivity, and inflammation will be calculated. Prevalence will be reported for categorical risk factors (e.g., HTN), and mean and standard deviation will be estimated for continuous risk factors (e.g., BP, lipid levels). The research team will also estimate the prevalence of each CVD outcome including MI, HF, and stroke.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Les Centres GHESKIO🌐 Port-au-Prince, West, Haiti