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

Sponsor
Weill Medical College of Cornell University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03892265
Collaborator
Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic (Other), National Heart, Lung, and Blood Institute (NHLBI) (NIH)
3,005
Enrollment
1
Location
64.8
Anticipated Duration (Months)
46.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators will establish a longitudinal cohort of 3,000 adults >18 years in Port-au-Prince using multistage random sampling, and follow them for 2 to 3.5 years depending on the timing of study enrollment 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 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.

Detailed Description

Investigators propose a 5-year observational study which includes establishing a population-based longitudinal cohort to determine the prevalence and incidence of cardiovascular risk factors and diseases in Haiti. Cardiovascular risk factors include hypertension, diabetes, obesity, kidney disease, dyslipidemia, smoking, alcohol use, physical inactivity, poor diet, and inflammation. Cardiovascular diseases include myocardial infarction, heart failure, stroke and cardiac death. The cohort will include 3,000 adults (>18 years) living in Port-au-Prince who will be followed for 2 to 3.5 years, depending on time of study enrollment. Participants will be selected via multistage random sampling using census blocks . The GHESKIO Community Advisory Board and GHESKIO community health workers (CHWs) will conduct community sensitization about the study prior to study recruitment. CHWs will introduce the study to selected households and individuals, who will then be referred to the research team at GHESKIO for informed consent and study enrollment procedures. Participants will complete the study enrollment, 12- and 24-month study visits at GHESKIO. These study visits include a study questionnaire, measurement of blood pressure and assessment for cardiovascular symptoms and events. Laboratory measures and an electrocardiogram will be done at study enrollment and the 24-month visit. Participants will also provide blood, urine and stool samples for biobanking at study enrollment and again at 24 months (blood only). CHWs will perform home visits at 6 and 18 months on all participants (and every six months after 24 months for patients with longer follow-up) to update locator information, measure blood pressure, and ask about cardiovascular symptoms and events. CHWs will also call the participant every three months to confirm contact information. Any participant who reports a cardiovascular symptom or event to research staff at any time during the study will be referred to the GHESKIO clinic or to a GHESKIO-affiliate hospital for clinical care. The research team will abstract data from medical records of referred patients on information regarding diagnosis codes, laboratory results, diagnostic imaging and cause of death.

Study Design

Study Type:
Observational
Actual Enrollment :
3005 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Actual Study Start Date :
Mar 8, 2019
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Outcome Measures

Primary Outcome Measures

  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 [Baseline, 24 months]

    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.

Secondary Outcome Measures

  1. Incidence of CVD risk factors and CVD during 2-3.5 years of follow-up and their association with social and environmental determinants [Participants will be followed for 2-3.5 years depending on timing of enrollment]

    Investigators will calculate the incidence rate of each CVD risk factor per 1000 person years (PY) of follow-up among participants without the respective CVD risk factor at baseline using a Horvitz-Thompson type estimator accounting for unequal sampling weights. Similarly, investigators will calculate the incidence rate of each CVD outcome among participants without the respective CVD at baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Les Centres GHESKIOPort-au-PrinceWestHaiti

Sponsors and Collaborators

  • Weill Medical College of Cornell University
  • Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic
  • National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Margaret McNairy, MD, MSc, Weill Medical College of Cornell University
  • Principal Investigator: Jean W Pape, MD, Weill Cornell Medical College /Les Centres GHESKIO

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT03892265
Other Study ID Numbers:
  • 1803019037
  • R01HL143788
First Posted:
Mar 27, 2019
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021