Global Cardiovascular Risk Consortium

Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Completed
CT.gov ID
NCT05466825
Collaborator
(none)
1,596,155
1
29.1
54772.2

Study Details

Study Description

Brief Summary

The Global Cardiovascular Risk Consortium (GCVRC) comprises harmonized data from nearly 1.7 Mio individuals of 126 cohorts across 43 countries and aims to elucidate the distribution of five major cardiovascular risk factors (body mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes) and their impact on cardiovascular disease (CVD) by geographical region and sex.

Detailed Description

Previous literature reported a small number of modifiable risk factors that might explain up to 90% of certain CVD subtypes. If and to what extent regional differences in risk factor levels contribute to new-onset CVD remains to be elucidated.

In the Global Cardiovascular Risk Consortium (GCVRC) we focus on five major cardiovascular risk factors: Body mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes. We aim to show the extent to which the distribution, population attributable risk, and predictive value of these factors differ geographically and by sex. Understanding of these issues is essential to guide regionally effective CVD prevention and therapy strategies, to determine residual risk, and to improve global cardiovascular health.

The GCVRC uses individual-level harmonized data from nearly 1.7 million individuals in 126 cohorts across 43 countries, categorized in 8 geographical regions (based on amodification of WHO regions) - North America, Latin America, Sub-Saharan Africa, North Africa and Middle East, Western Europe, Eastern Europe and Russia, Asia, Oceania.

Cox regression analyses and population attributable fractions (PAFs) for 10-year incident CVD are calculated for the five risk factors by geographical region and sex to determine the percentage of CVD burden that may be preventable by control of these risk factors.

The results will influence regionally adapted prevention strategies to reduce the global CVD burden.

Study Design

Study Type:
Observational
Actual Enrollment :
1596155 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Impact of Modifiable Cardiovascular Risk Factors on Incident Cardiovascular Disease by Geographical Region and Sex
Actual Study Start Date :
Sep 20, 2019
Actual Primary Completion Date :
Feb 23, 2022
Actual Study Completion Date :
Feb 23, 2022

Outcome Measures

Primary Outcome Measures

  1. Cardiovascular disease (CVD) [5-7 years of follow-up]

    Non-fatal myocardial infarction, ischemic heart disease death, unstable angina pectoris, cardiac revascularization, unclassifiable death, fatal and non-fatal stroke (any type).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • population-based cohort: individuals with information on the traditional CVD risk factors including body mass index (BMI), systolic blood pressure (SBP), non-high-density lipoprotein cholesterol (non-HDL-C), current smoking, and diabetes, as well as the outcome fatal or non-fatal CVD.
Exclusion Criteria:
  • participants with age below 18 years

  • no information on the outcome of interest (CVD incidence or mortality)

  • no information on the exposure of interest (CVD risk factors)

  • History of CVD at baseline

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Medical Center Hamburg-Eppendorf Hamburg Germany 20251

Sponsors and Collaborators

  • Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Study Chair: Prof. Dr. med. Stefan Blankenberg, Universitätsklinikum Hamburg-Eppendorf

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Prof. Dr. Stefan Blankenberg, Prof. Dr. med., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT05466825
Other Study ID Numbers:
  • GCVRC001
First Posted:
Jul 20, 2022
Last Update Posted:
Jul 20, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Prof. Dr. Stefan Blankenberg, Prof. Dr. med., Universitätsklinikum Hamburg-Eppendorf
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 20, 2022