Coronary Artery DiseaseCOPE registryNCT04834843
Temporal Trends of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea
An observational study of Coronary Artery Disease and Peripheral Artery Disease, run by Wonju Severance Christian Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Peripheral Artery Disease, Cardiovascular Diseases
- How many people
- 700,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2009to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- less than 18 years old
About this study
Official title: 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.
- Being tested
- Observational study, no intervention
- Medical subject headings
- Coronary Artery Disease, Peripheral Arterial Disease, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational study, no interventionOther
Observational study, no intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of coronary artery disease, cerebrovascular disease, peripheral arterial disease
Among all Koreans, percentage (%) of patients with a history of being diagnosed with CVD and underwent in-hospital treatment
Measured: Up to 10 years
Secondary outcomes (1)
1-year mortality
The percentage (%) of any CVD related mortality
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start1 Jan 2009
- Primary completion31 Dec 2018
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wonju Severance Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong-Hyuk Cho, Wonju Severance Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04834843
- Sponsor's protocol ID
- 2020AN0279
- Acronym
- COPE registry
- Status last verified
- Apr 2021
- First submitted
- 5 Apr 2021
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD from Korean national health insurance is not publicly accessible due to Korean personal information projection act
Publications
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.
PubMed 31883328Bhatt 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.
PubMed 16403930Ahn 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.
PubMed 22690093Sogaard 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.
PubMed 33300375
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Temporal Trends in the Incidence, Treatment Patterns, and Outcomes of COronary Artery Disease and PEripheral Artery Disease (COPE) in Korea
- ClinicalTrials.gov ID
- NCT04834843
- Acronym / sponsor ID
- COPE registry / 2020AN0279
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700,000 participants (actual)
- Lead sponsor
- Wonju Severance Christian HospitalUniversity, hospital or other
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 8 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- less than 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational study, no interventionObservational study, no intervention | Other | – |
Primary outcome
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
1 secondary outcome
1-year mortality
Time frame: Up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
- Results publication: PubMed 31883328Sundaram 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.
- Results publication: PubMed 16403930Bhatt 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.
- Results publication: PubMed 22690093Ahn 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.
- Results publication: PubMed 33300375Sogaard 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.
- Individual participant dataSharing planned: No. The IPD from Korean national health insurance is not publicly accessible due to Korean personal information projection act
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Peripheral Artery Disease, run by Wonju Severance Christian Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of coronary artery disease, cerebrovascular disease, peripheral arterial disease (time frame: Up to 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04834843, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.