Clinical trial NCT05466825: The Global Cardiovascular Risk Consortium
Official title: Predicting Cardiovascular Risk by Geographical Region and Sex Using Classical Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: All-cause Mortality
Cardiovascular Disease
Keywords: Cardiovascular Disease
Cardiovascular Risk Factors
Risk Factor Modification
Global
Lifetime Gain
Lead sponsor: Universitätsklinikum Hamburg-Eppendorf
Sponsor class: OTHER
First posted: 2022-07-20
Enrollment: 2500000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The GCVRC uses harmonized individual-level data from currently more than 2 Mio individuals from 133 cohorts, 39 countries and 6 continents, categorized in 8 geographical regions - North America, Latin America, Sub-Saharan Africa, North Africa and the Middle East, Western Europe, Eastern Europe and Russia, Asia, and Oceania.

The database provides information on cardiovascular risk factors, including body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes, as well as data on major outcomes.

Brief summary: The Global Cardiovascular Risk Consortium (GCVRC) brings together harmonized individual-level data from over 2 million individuals across 133 cohorts, 39 countries, and 6 continents, with recruitment ongoing. The GCVRC examines the impact of classical cardiovascular risk factors-such as body mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes-on cardiovascular disease (CVD) and death from any cause worldwide.

Detailed description: A small number of modifiable risk factors may account for a significant proportion of cardiovascular disease (CVD) risk. However, the CVD burden attributable to classical risk factors depends on the populations studied and the methodologies used.

The Global Cardiovascular Risk Consortium (GCVRC) is an international collaboration that continuously includes cohort studies from around the world to improve cardiovascular risk prediction. The GCVRC uses extensively harmonized individual-level data from currently more than 2 Mio individuals from 133 cohorts, 39 countries and 6 continents categorized in 8 geographical regions (based on a modification of WHO and United Nations definitions) - North America, Latin America, Sub-Saharan Africa, North Africa and the Middle East, Western Europe, Eastern Europe and Russia, Asia, and Oceania.

The consortium has a special focus on classical, potentially modifiable cardiovascular risk factors: Body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes. Key research questions include examining the impact of these factors on major outcomes by geographical region and sex, as well as estimating associated lifetime risk and the potential lifetime difference when modifying these risk factors.

This work is critical for developing regionally tailored CVD prevention and treatment strategies, identifying residual risk, and improving global cardiovascular health. Based on GCVRC data, a landmark paper on the effect of classical risk factors on new-onset CVD and all-cause mortality was published in the New England Journal of Medicine in 2023 (https://doi.org/10.1056/nejmoa2206916).

Eligibility criteria: Inclusion Criteria:

Population-based individual-level data with available information on the classical cardiovascular risk factors including body-mass index, systolic blood pressure, non-high-density lipoprotein cholesterol, current smoking, and diabetes, as well as the outcomes of interest.

Exclusion Criteria:

* Participants with age below 18 years
* No information on the outcome of interest
* No information on the exposure of interest (CVD risk factors)
* History of CVD at baseline

Primary outcomes:
measure: Cardiovascular disease (CVD)
timeFrame: Median follow-up of 7-10 years
measure: All-cause mortality (ACM)
timeFrame: Median follow-up of 7-10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: University Medical Center Hamburg-Eppendorf
Study officials:
affiliation: Universitätsklinikum Hamburg-Eppendorf
name: Prof. Dr. med. Stefan Blankenberg
role: STUDY_CHAIR
References:
citation: Global Cardiovascular Risk Consortium; Magnussen C, Ojeda FM, Leong DP, Alegre-Diaz J, Amouyel P, Aviles-Santa L, De Bacquer D, Ballantyne CM, Bernabe-Ortiz A, Bobak M, Brenner H, Carrillo-Larco RM, de Lemos J, Dobson A, Dorr M, Donfrancesco C, Drygas W, Dullaart RP, Engstrom G, Ferrario MM, Ferrieres J, de Gaetano G, Goldbourt U, Gonzalez C, Grassi G, Hodge AM, Hveem K, Iacoviello L, Ikram MK, Irazola V, Jobe M, Jousilahti P, Kaleebu P, Kavousi M, Kee F, Khalili D, Koenig W, Kontsevaya A, Kuulasmaa K, Lackner KJ, Leistner DM, Lind L, Linneberg A, Lorenz T, Lyngbakken MN, Malekzadeh R, Malyutina S, Mathiesen EB, Melander O, Metspalu A, Miranda JJ, Moitry M, Mugisha J, Nalini M, Nambi V, Ninomiya T, Oppermann K, d'Orsi E, Pajak A, Palmieri L, Panagiotakos D, Perianayagam A, Peters A, Poustchi H, Prentice AM, Prescott E, Riserus U, Salomaa V, Sans S, Sakata S, Schottker B, Schutte AE, Sepanlou SG, Sharma SK, Shaw JE, Simons LA, Soderberg S, Tamosiunas A, Thorand B, Tunstall-Pedoe H, Twerenbold R, Vanuzzo D, Veronesi G, Waibel J, Wannamethee SG, Watanabe M, Wild PS, Yao Y, Zeng Y, Ziegler A, Blankenberg S. Global Effect of Modifiable Risk Factors on Cardiovascular Disease and Mortality. N Engl J Med. 2023 Oct 5;389(14):1273-1285. doi: 10.1056/NEJMoa2206916. Epub 2023 Aug 26.