- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04834843
Temporal Trends of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea (COPE registry)
April 5, 2021 updated by: Dong-Hyuk Cho, Wonju Severance Christian Hospital
Temporal Trends in the Incidence, Treatment Patterns, and Outcomes of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea
Cardiovascular disease (CVD) is caused by atherosclerosis of the artery and is classified into coronary artery disease, cerebrovascular disease, and peripheral arterial disease, depending on the location of the artery and the target organs.
However, since CVD share a similar pathophysiology and the probability of incidence of other CVD in CVD patients is very high.
It is thought that CVD incidence and mortality can be reduced by predicting the degree of incidence of other CVD in CVD patients.
The aim of this study is to investigate the incidence and mortality of other CVD diseases in CVD patients.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
700000
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
People aged at least 18 years old with CAD, PAD, or cerebrovascular disease were identified from Korean national health insurance using International Classification of Diseases, tenth revision (ICD-10) codes.
Description
Inclusion Criteria:
- Koreans who diagnosed with coronary artery disease between 2009 and 2018
- Koreans who diagnosed with peripheral artery disease between 2009 and 2018
- Koreans who diagnosed with cerebrovascular disease between 2009 and 2018
- more than 18 years old
Exclusion Criteria:
- less than 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of coronary artery disease, cerebrovascular disease, peripheral arterial disease
Time Frame: Up to 10 years
|
Among all Koreans, percentage (%) of patients with a history of being diagnosed with CVD and underwent in-hospital treatment
|
Up to 10 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
1-year mortality
Time Frame: Up to 1 year
|
The percentage (%) of any CVD related mortality
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Bhatt DL, Steg PG, Ohman EM, Hirsch AT, Ikeda Y, Mas JL, Goto S, Liau CS, Richard AJ, Rother J, Wilson PW; REACH Registry Investigators. International prevalence, recognition, and treatment of cardiovascular risk factors in outpatients with atherothrombosis. JAMA. 2006 Jan 11;295(2):180-9. doi: 10.1001/jama.295.2.180.
- Sundaram V, Bloom C, Zakeri R, Halcox J, Cohen A, Bowrin K, Briere JB, Banerjee A, Simon DI, Cleland JGF, Rajagopalan S, Quint JK. Temporal trends in the incidence, treatment patterns, and outcomes of coronary artery disease and peripheral artery disease in the UK, 2006-2015. Eur Heart J. 2020 May 1;41(17):1636-1649. doi: 10.1093/eurheartj/ehz880.
- Ahn S, Park YJ, Min SI, Kim SY, Ha J, Kim SJ, Kim HS, Yoon BW, Min SK. High prevalence of peripheral arterial disease in Korean patients with coronary or cerebrovascular disease. J Korean Med Sci. 2012 Jun;27(6):625-9. doi: 10.3346/jkms.2012.27.6.625. Epub 2012 May 26.
- Sogaard M, Nielsen PB, Skjoth F, Eldrup N, Larsen TB. Temporal Changes in Secondary Prevention and Cardiovascular Outcomes After Revascularization for Peripheral Arterial Disease in Denmark: A Nationwide Cohort Study. Circulation. 2021 Mar 2;143(9):907-920. doi: 10.1161/CIRCULATIONAHA.120.047994. Epub 2020 Dec 10.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 1, 2009
Primary Completion (ACTUAL)
December 31, 2018
Study Completion (ACTUAL)
December 31, 2020
Study Registration Dates
First Submitted
April 5, 2021
First Submitted That Met QC Criteria
April 5, 2021
First Posted (ACTUAL)
April 8, 2021
Study Record Updates
Last Update Posted (ACTUAL)
April 8, 2021
Last Update Submitted That Met QC Criteria
April 5, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020AN0279
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
The IPD from Korean national health insurance is not publicly accessible due to Korean personal information projection act
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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