Coronary Artery DiseaseNCT04778969
Kor PCI - CAD Patients Treated With PCI: Analysis of the Korean Nationwide Health Insurance Database
An observational study of Coronary Artery Disease and Drug-eluting Stents, run by Seoul National University Hospital.
Trial summary
Current Status and Prognosis of Coronary artery disease patients treated with coronary intervention - Analysis of the Korean Nationwide Health Insurance Database Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Drug-eluting Stents, Drug-coated Balloon
- What is being tested?
- drug-eluting stent and drug-coated balloon
- Type of treatment
- Medical device
- How many people
- 200,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2021to 1 Apr 2021
- 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: All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI Patients are selected based on the registered treatment insurance code.
Who may be able to join
- All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI
Who cannot join
- non-specified
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention: Analysis of the Korean Nationwide Health Insurance Database
Current Status and Prognosis of Coronary artery disease patients treated with coronary intervention - Analysis of the Korean Nationwide Health Insurance Database
Read the detailed description
This is a retrospective study and is conducted for all patients who received percutaneous coronary intervention among cohorts registered with the National Health Insurance Service.
Primary outcome is all cause of mortality. Secondary outcomes are cardiovascular death, ischemic stroke, cerebral hemorrhage, admission due to gastrointestinal bleeding, and admission due to major bleedings.
- Being tested
- drug-eluting stent, drug-coated balloon
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
drug-eluting stentDevice
Also called DES group
A group of percutaneous coronary intervention (PCI) using drug-eluting stents (DES)
drug-coated balloonDevice
Also called DCB group
A group of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB)
What is being measured
The primary outcome is the main question the study is designed to answer.
All cause of death
'All cause of death' will be recorded as number of participants with 'All cause of death'
Measured: 10 years
Secondary outcomes (5)
Cardiovascular death
'Cardiovascular death' will be recorded as number of participants with 'Cardiovascular death'
Measured: 10 years
ischemic stroke
'ischemic stroke' will be recorded as number of participants with 'ischemic stroke'
Measured: 10 years
Cerebral hemorrhage
'Cerebral hemorrhage' will be recorded as number of participants with 'Cerebral hemorrhage'
Measured: 10 years
Admission due to gastrointestinal bleeding
'Admission due to gastrointestinal bleeding' will be recorded as number of participants with 'Admission due to gastrointestinal bleeding'
Measured: 10 years
Admission due to major bleeding
'Admission due to major bleeding' will be recorded as number of participants with 'Admission due to major bleeding' Thismeasure is a composite outcome, which includes cerebral hemorrhage, admission due to gastrointestinal bleeding.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study start1 Apr 2021 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 200,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Han-Mo Yang, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04778969
- Sponsor's protocol ID
- E-2009-016-1154
- Status last verified
- Feb 2021
- First submitted
- 13 Jan 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since this research is conducted with a national public institution, data cannot be shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Disease Patients Treated With Percutaneous Coronary Intervention: Analysis of the Korean Nationwide Health Insurance Database
- ClinicalTrials.gov ID
- NCT04778969
- Acronym / sponsor ID
- E-2009-016-1154
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 1 Apr 2021 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Apr 2021 (estimated)
- First posted
- 3 Mar 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.
Current Status and Prognosis of Coronary artery disease patients treated with coronary intervention - Analysis of the Korean Nationwide Health Insurance Database
Detailed description
This is a retrospective study and is conducted for all patients who received percutaneous coronary intervention among cohorts registered with the National Health Insurance Service.
Primary outcome is all cause of mortality. Secondary outcomes are cardiovascular death, ischemic stroke, cerebral hemorrhage, admission due to gastrointestinal bleeding, and admission due to major bleedings.
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
- All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI Patients are selected based on the registered treatment insurance code.
Key inclusion criteria (1 listed)
- All coronary artery disease patients wih Korean NHIS (National Health Insurance Service)-listed PCI
Key exclusion criteria (1 listed)
- non-specified
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 |
|---|---|---|
| drug-eluting stentAlso: DES groupA group of percutaneous coronary intervention (PCI) using drug-eluting stents (DES) | Device | – |
| drug-coated balloonAlso: DCB groupA group of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB) | Device | – |
Primary outcome
All cause of death
Time frame: 10 years
'All cause of death' will be recorded as number of participants with 'All cause of death'
5 secondary outcomes
Cardiovascular death
Time frame: 10 years
ischemic stroke
Time frame: 10 years
Cerebral hemorrhage
Time frame: 10 years
Admission due to gastrointestinal bleeding
Time frame: 10 years
Admission due to major bleeding
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: No. Since this research is conducted with a national public institution, data cannot be shared.
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Drug-eluting Stents, run by Seoul National University 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 1 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: status not confirmed, as of the sponsor's last update on 3 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Han-Mo Yang, MD, PhD (8220722677, hanname@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All cause of death (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2021.