A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti (NCT03892265) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Haiti3,005 participantsStarted 2019-03-08
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is observational and is tracking cardiovascular risk factors like hypertension, diabetes, and obesity in a Haitian adult population — since it's not testing a treatment, what would participating actually involve for me, and could it help my own care in any way?
2The trial is listed as 'active not recruiting,' meaning they are no longer enrolling new participants — does that mean there's no way for me to join, and are there similar studies I might be eligible for instead?
3Since this research is focused on understanding how social and environmental factors contribute to heart disease, stroke, and kidney disease in Haiti, could the findings from this kind of study be relevant to my own cardiovascular risk assessment, especially if I have a Haitian background?
4Given that this study is measuring conditions I may already have — like hypertension, diabetes, or high cholesterol — should I be asking for a more comprehensive cardiovascular risk evaluation based on what research like this is learning about how these conditions interact?
5Are there any active clinical trials testing actual treatments or interventions for the cardiovascular conditions this study tracks, like heart failure or stroke prevention, that might be worth exploring given my personal health situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prevalence of CVD risk factors and diseases and their association with social and environmental determinants in an established longitudinal cohort of ~3,000 Haitian adults
Timeframe: Baseline
Trial details
NCT IDNCT03892265
SponsorWeill Medical College of Cornell University