Plain English Summary
Background and study aims
Atherosclerosis is the build-up of fatty material inside the arteries (blood vessels), which leads to heart attacks and strokes. It can be treated with a procedure called percutaneous coronary intervention (PCI), where a short wire-mesh tube, called a stent, is inserted into the artery to allow the blood to flow more freely. The aim of this study is to set up a registry (database) to follow the clinical outcomes of patients who have undergone PCI for atherosclerosis in order to improve the quality of patient care.
Who can participate?
Patients over 20 years old who have undergone PCI for atherosclerosis
What does the study involve?
Clinical data is collected about patients who underwent PCI at Chang Gung Memorial Hospital since November 1995. Deaths, heart attacks, and further stenting/surgery are all measured. The patients do not undergo any additional tests or treatment for the purposes of this study.
What are the possible benefits and risks of participating?
The results of this study may improve the quality of patient care. There are no risks involved.
Where is the study run from?
Chang Gung Memorial Hospital (Taiwan)
When is the study starting and how long is it expected to run for?
June 2011 to June 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr I-Chang Hsieh
Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions (CAPTAIN)
The CAPTAIN registry is a prospective, physician-initiated, single-center observational database to evaluate patients' clinical and angiographic outcome after stenting with different type stents.
Previous studies has showed thant the use of drug eluting stent (DES) is associated with better angiographical outcome then the baremetal stent (BMS) did in coronary artery lesions, however, the results in different vessels, patients, or stent designs varied. This observational registry is to evaluate the clinical and angiographic outcome of different settings.
Institutional Review Board of Chang Gung Memorial Hospital Medical Foundation, 21/06/2011
Prospective single-center observational study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Coronary disease receiving coronary artery stents
The coronary intervention results and prognosis of 5000 people before June 2011 were traced via medical record review and telephone follow-up. These data were all digitized. All clinical data were collected and the prognosis of all patients receiving PCI was evaluated. Data was analyzed with t-test or analysis of variance (ANOVA) with post hoc Tukey and Duncan tests via SPSS software. P value below 0.05 was meaningful statistically.
Primary outcome measure
Major adverse cardiac event (MACE) such as cardiac death, myocardial infarction (STEMI or NSTEMI), target lesion revascularization (TLR), stenting in a new lesion, and the need for emergency bypass surgery during long-term follow-up after coronary stentings
Secondary outcome measures
Cardiovascular events during the follow-up period including total death (cardiac and non-cardiac), reinfarction (STEMI or NSTEMI), or a cerebrovascular accident (CVA) after coronary stentings
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Evidence of myocardial ischemia
2. >50% stenosis in a native coronary artery or in a bypass vein graft that was suitable for stenting
3. Over 20 years old
4. Had received coronary intervention
5. Patient and family members agreed to further follow-up
Target number of participants
Participant exclusion criteria
1. Severe multivessel disease requiring bypass surgery
2. Contraindication for aspirin, ticlopidine, clopidogrel or ticagrelor use
3. Patients who refused to undergo the procedure
4. Patients who refused further follow-up
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Chang Gung Memorial Hospital
No. 5 Fu-Hsing Street Kweishan
Chang Gung Medical Foundation
No. 5 Fu-Hsing Street
Investigator initiated and funded
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
IPD sharing plan
For the sake of confidentiality of personal data, participant level data is not expected to be available.
Intention to publish date
Participant level data
Not expected to be available
Basic results (scientific)
1. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23571311
2. 2013 results in: https://www.ncbi.nlm.nih.gov/pubmed/23592601
3. 2014 results in: https://www.ncbi.nlm.nih.gov/pubmed/24727795
4. 2015 results in: https://www.ncbi.nlm.nih.gov/pubmed/26406989
5. 2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27620336