Condition category
Circulatory System
Date applied
23/09/2016
Date assigned
20/11/2016
Last edited
18/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr I-Chang Hsieh

ORCID ID

Contact details

No. 5 Fu-Hsing Street
Kweishan
Taoyuan
333
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

CORPG3C0162

Study information

Scientific title

Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions (CAPTAIN)

Acronym

CAPTAIN

Study hypothesis

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.

Ethics approval

Institutional Review Board of Chang Gung Memorial Hospital Medical Foundation, 21/06/2011

Study design

Prospective single-center observational study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet

Condition

Coronary disease receiving coronary artery stents

Intervention

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.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

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

16/06/2011

Overall trial end date

15/06/2021

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20000

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

16/06/2011

Recruitment end date

15/06/2021

Locations

Countries of recruitment

Taiwan

Trial participating centre

Chang Gung Memorial Hospital
No. 5 Fu-Hsing Street Kweishan
Taoyuan
333
Taiwan

Sponsor information

Organisation

Chang Gung Medical Foundation

Sponsor details

No. 5 Fu-Hsing Street
Kweishan
Taoyuan
-
Taiwan

Sponsor type

Hospital/treatment centre

Website

https://www.cgmh.org.tw/eng2002/center_main.htm

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

30/06/2017

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

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

Publication citations

Additional files

Editorial Notes