- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05466825
The Global Cardiovascular Risk Consortium
Predicting Cardiovascular Risk by Geographical Region and Sex Using Classical Cardiovascular Risk Factors
Study Overview
Status
Conditions
Detailed Description
A small number of modifiable risk factors accounts 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 million individuals from 133 cohorts, 40 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 Australia.
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 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 (doi.org/10.1056/nejmoa2206916), followed by a study evaluating the effect of classical risk factors on different lifetime estimates, also published in the New England Journal of Medicine in 2025 (doi: 10.1056/NEJMoa2415879).
Further studies evaluate the effect of projecting risk factor reductions on CVD and all-cause mortality at the population level.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Prof. Dr. med. Stefan Blankenberg
- Phone Number: +49 (0)40 741056800
- Email: s.blankenberg@uke.de
Study Contact Backup
- Name: Prof. Dr. med. Christina Magnussen
- Phone Number: +49 (0) 40 741058206
- Email: c.magnussen@uke.de
Study Locations
-
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Hamburg
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Hamburg, Hamburg, Germany, 20251
- Recruiting
- University Medical Center Hamburg-Eppendorf
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Contact:
- Prof. Dr. med. Stefan Blankenberg
- Phone Number: +49 (0)40 741056800
- Email: s.blankenberg@uke.de
-
Contact:
- Prof. Dr. med. Christina Magnussen
- Phone Number: +49 (0)40 741058206
- Email: c.magnussen@uke.de
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
The GCVRC uses harmonized individual-level data from currently more than 2 Mio individuals from 133 cohorts, 40 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 Australia.
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 cardiovascular outcomes and death.
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Cardiovascular disease (CVD)
Time Frame: Median follow-up of 7-10 years
|
Event rates of CVD and CVD subtypes: First fatal or non-fatal myocardial infarction, unstable angina, coronary revascularization, ischemic or hemorrhagic stroke, and cardiovascular or unclassifiable death.
The type of outcome measurement varies across cohorts.
CVD cases and subtypes are 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.
|
Median follow-up of 7-10 years
|
|
Death from any cause
Time Frame: Median follow-up of 7-10 years
|
Number of deaths from any cause.
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Median follow-up of 7-10 years
|
Collaborators and Investigators
Investigators
- Study Chair: Prof. Dr. med. Stefan Blankenberg, Universitätsklinikum Hamburg-Eppendorf
Publications and helpful links
General Publications
- 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.
- Global Cardiovascular Risk Consortium; Magnussen C, Alegre-Diaz J, Al-Nasser LA, Amouyel P, Aviles-Santa L, Bakker SJL, Ballantyne CM, Bernabe-Ortiz A, Bobak M, Boffetta P, Brenner H, Brunstrom M, Can G, Carrillo-Larco RM, Checkley W, Dallongeville J, De Bacquer D, de Gaetano G, de Lemos JA, di Carluccio E, Dobson A, Donfrancesco C, Dorr M, d'Orsi E, Drygas W, Dullaart RPF, Engstrom G, Ferrario MM, Ferrieres J, Figtree GA, Gaye B, Ghayour-Mobarhan M, Goldbourt U, Gonzalez C, Gossling A, Grassi G, Gupta PC, He J, Hodge AM, Hozawa A, Hveem K, Iacoviello L, Ikram MK, Inoue M, Irazola V, Jobe M, Jousilahti P, Kaleebu P, Kavousi M, Kee F, Khalili D, Klotsche J, Koenig W, Kontsevaya A, Kowlessur S, Kuri-Morales P, Kuulasmaa K, Kweon SS, Lackner KJ, Landmesser U, Leistner DM, Leiva Sisnieguez CE, Leong D, Lind L, Linneberg A, Lorenz T, Lyngbakken MN, Malekzadeh R, Malyutina S, Mathiesen EB, McElduff P, Melander O, Metspalu A, Miranda JJ, Moitry M, Mugisha J, Munzinger J, Nalini M, Nambi V, Nilsson PM, Ninomiya T, Omland T, Ong SK, Oppermann K, Pajak A, Palmieri L, Panagiotakos D, Park SK, Pednekar MS, Perianayagam A, Peters A, Poustchi H, Prabhakaran D, Prentice AM, Prescott E, Quyyumi A, Riserus U, Sakata S, Salazar M, Salomaa V, Sans S, Sattler ELP, Schottker B, Schutte AE, Sepanlou SG, Sharma SK, Shaw J, Simons LA, Soderberg S, Tamosiunas A, Tapia-Conyer R, Thorand B, Tunstall-Pedoe H, Tuomilehto J, Twerenbold R, Vanuzzo D, Veronesi G, Wannamethee SG, Watanabe M, Weimann J, Wild PS, Yao Y, Zeng Y, Ziegler A, Ojeda FM, Blankenberg S; The Global Cardiovascular Risk Consortium. Global Effect of Cardiovascular Risk Factors on Lifetime Estimates. N Engl J Med. 2025 Jul 10;393(2):125-138. doi: 10.1056/NEJMoa2415879. Epub 2025 Mar 30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GCVRC001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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