Cardiovascular atherosclerosis and percutaneous transluminal interventions

ISRCTN	ISRCTN12810677
DOI	https://doi.org/10.1186/ISRCTN12810677
Secondary identifying numbers	CORPG3C0162

Submission date: 23/09/2016
Registration date: 20/11/2016
Last edited: 18/11/2016

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr I-Chang Hsieh
Scientific

No. 5 Fu-Hsing Street, Kweishan
Taoyuan
333
Taiwan

Study information

Study design	Prospective single-center observational study
Primary study design	Observational
Secondary study design	Cohort study
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a patient information sheet
Scientific title	Cardiovascular Atherosclerosis and Percutaneous TrAnsluminal INterventions (CAPTAIN)
Study acronym	CAPTAIN
Study objectives	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(s)	Institutional Review Board of Chang Gung Memorial Hospital Medical Foundation, 21/06/2011
Health condition(s) or problem(s) studied	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
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 study start date	16/06/2011
Completion date	15/06/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	20000
Key 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
Key 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
Date of first enrolment	16/06/2011
Date of final enrolment	15/06/2021

Locations

Countries of recruitment

Taiwan

Study participating centre

Chang Gung Memorial Hospital

No. 5 Fu-Hsing Street
Kweishan
Taoyuan
333
Taiwan

Sponsor information

Chang Gung Medical Foundation
Hospital/treatment centre

No. 5 Fu-Hsing Street
Kweishan
Taoyuan
-
Taiwan

Website	https://www.cgmh.org.tw/eng2002/center_main.htm
"ROR"	https://ror.org/02verss31

Funders

Funder type

Other

Investigator initiated and funded

No information available

Results and Publications

Intention to publish date	30/06/2017
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan
IPD sharing plan	For the sake of confidentiality of personal data, participant level data is not expected to be available.

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/05/2013	Yes	No
Results article	results	01/11/2013	Yes	No
Results article	results	11/04/2014	Yes	No
Results article	results	25/09/2015	Yes	No
Results article	results	01/07/2017	Yes	No