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Global Cardiovascular Risk Consortium

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05466825
Recruitment Status : Completed
First Posted : July 20, 2022
Last Update Posted : November 22, 2022
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Stefan Blankenberg, Universitätsklinikum Hamburg-Eppendorf

Study Description
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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.

Condition or disease
Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Infarction Angina, Unstable Stroke Myocardial Revascularization

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
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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 : September 20, 2019
Actual Primary Completion Date : February 23, 2022
Actual Study Completion Date : February 23, 2022
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Cardiovascular disease (CVD) [ Time Frame: 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). 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Within the Global Cardiovascular Risk Consortium we used individual-level harmonized data from nearly 1.7 million individuals in 126 cohorts across 43 countries, categorized in 8 geographical regions - North America, Latin America, Sub-Saharan Africa, North Africa and Middle East, Western Europe, Eastern Europe and Russia, Asia, and Oceania.

The cohort offers data on the CVD risk factors including body mass index (BMI), systolic blood pressure (SBP), non-high-density lipoprotein cholesterol (non-HDL-C), current smoking, and diabetes.

Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05466825


Locations
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Germany
University Medical Center Hamburg-Eppendorf
Hamburg, Germany, 20251
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
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Study Chair: Prof. Dr. med. Stefan Blankenberg Universitätsklinikum Hamburg-Eppendorf
More Information
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Publications:
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, Soderberg S, Linneberg A, Brenner H, Amouyel P, Ferrieres J, Tamosiunas A, Nikitin YP, Drygas W, Melander O, Jockel KH, Leistner DM, Shaw JE, Panagiotakos DB, Simons LA, Kavousi M, Vasan RS, Dullaart RPF, Wannamethee SG, Riserus 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;: Lancet. 2020 Jan 4;395(10217):32.

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Responsible Party: Prof. Dr. Stefan Blankenberg, Prof. Dr. med., Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT05466825    
Other Study ID Numbers: GCVRC001
First Posted: July 20, 2022    Key Record Dates
Last Update Posted: November 22, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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, Universitätsklinikum Hamburg-Eppendorf:
cardiovascular disease
cardiovascular risk factors
risk factor modification
global
population-attributable fraction
 geographical comparison
myocardial infarction
coronary heart disease
stroke
heart disease
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Coronary Disease
Angina, Unstable
Infarction
Vascular Diseases
Ischemia
 Pathologic Processes
Necrosis
Myocardial Ischemia
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations