Global Cardiovascular Risk Consortium

Stroke Clinical Trial

Official title:

Impact of Modifiable Cardiovascular Risk Factors on Incident Cardiovascular Disease by Geographical Region and Sex

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05466825
• Other study ID #: GCVRC001
• Status: Completed
• Start date: September 20, 2019
• Est. completion date: February 23, 2022

Study information

• Verified date: November 2022
• Source: Universitätsklinikum Hamburg-Eppendorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1596155
• Est. completion date: February 23, 2022
• Est. primary completion date: February 23, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angina, Unstable
• Cardiovascular Diseases
• Coronary Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• Myocardial Revascularization
• Stroke

Locations

Country	Name	City	State
Germany	University Medical Center Hamburg-Eppendorf	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Universitätsklinikum Hamburg-Eppendorf

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Brunner FJ, Waldeyer C, Ojeda F, Salomaa V, Kee F, Sans S, Thorand B, Giampaoli S, Brambilla P, Tunstall-Pedoe H, Moitry M, Iacoviello L, Veronesi G, Grassi G, Mathiesen EB, Söderberg S, Linneberg A, Brenner H, Amouyel P, Ferrières J, Tamosiunas A, Nikitin YP, Drygas W, Melander O, Jöckel KH, Leistner DM, Shaw JE, Panagiotakos DB, Simons LA, Kavousi M, Vasan RS, Dullaart RPF, Wannamethee SG, Risérus U, Shea S, de Lemos JA, Omland T, Kuulasmaa K, Landmesser U, Blankenberg S; Multinational Cardiovascular Risk Consortium. Application of non-HDL cholesterol for population-based cardiovascular risk stratification: results from the Multinational Cardiovascular Risk Consortium. Lancet. 2019 Dec 14;394(10215):2173-2183. doi: 10.1016/S0140-6736(19)32519-X. Epub 2019 Dec 3. Erratum in: Lancet. 2019 Dec 6;:. Erratum in: Lancet. 2020 Jan 4;395(10217):32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiovascular disease (CVD)	Non-fatal myocardial infarction, ischemic heart disease death, unstable angina pectoris, cardiac revascularization, unclassifiable death, fatal and non-fatal stroke (any type). The type of outcome measurement varied across cohorts. CVD cases and subtypes were assessed by questionnaire information, national hospital discharge registry data, causes of death registry data or central death registries depending on the study protocol of the respective cohort studies.	5-7 years of follow-up