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CathOlic Medical Center percutAneous Coronary inTervention Registry (COACT)

This study is currently recruiting participants.
Verified July 2010 by The Catholic University of Korea
Sponsor:
Collaborators:
Seoul St. Mary's Hospital
Yeouido St.Mary's Hospital
UiJeungbu St.Mary's Hospital
Bucheon St.Mary's Hospital
St.Paul's Hospital, Korea
Incheon St.Mary's Hospital
St.Vincent's Hospital of Korea
Daejeon St.Mary's Hospital
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT01239914
First received: November 12, 2010
Last updated: August 24, 2012
Last verified: July 2010
History of Changes
  Purpose

COACT registry is a multicenter registry of consecutive patients undergoing coronary stent implantation at 8 centers in the Catholic University of Korea to evaluate the real world management of patients with coronary artery disease and to assess their in-hospital, medium and long-term outcomes.


Condition
Drug Eluting Stent
Coronary Artery Disease
Polymorphism
Cholesterol
Biomarker

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: CathOlic Medical Center percutAneous Coronary inTervention Registry (COACT)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • All causes mortality [ Time Frame: 6month, each year ] [ Designated as safety issue: Yes ]
  • Cardiac death [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]
  • Myocardial infarction [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]
  • target lesion revascularization [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]
  • target vessel revascularization [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • non target vessel revascularization [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]
  • Serum databank for evaluation of biomarkers outcomes [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]
  • Pharmacogenetic and cardiovascular genetic studies associated to clinical outcomes [ Time Frame: 6 month, each year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Whole blood, serum and DNA


Estimated Enrollment: 11000
Study Start Date: January 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

all comers who admitted cardiovascular center for coronary stent implantation

Criteria

Inclusion Criteria:

  • all consecutive patients who underwent percutaneous coronary intervention
  • written informed consent for the DNA and serum databank

Exclusion Criteria:

  • patients who did not agreed to participate
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239914

Contacts
Contact: Ki-Bae Seung, M.D., PhD +82-2-2258-1142 kbseung@catholic.ac.kr

Locations
Korea, Republic of
Bucheon St.Mary Hospital Recruiting
Bucheon, Gyeonggido, Korea, Republic of
Contact: Hee Yeol Kim, M.D.            
St.Vincent's Hospital Recruiting
Suwon, Gyeonggido, Korea, Republic of
Contact: Ki-Dong Yoo, M.D.            
Uijeongbu St.Mary's Hospital Recruiting
Uijeongbu, Gyeonggido, Korea, Republic of
Contact: Yoon-seok Koh, M.D.            
Daejeon St.Mary's Hospital Recruiting
Daejeon, Korea, Republic of
Contact: Sung-Ho Hur, M.D.            
Incheon St.Mary's Hospital Recruiting
Incheon, Korea, Republic of
Contact: Dong-Il Shin, M.D.            
St.Paul's Hospital Recruiting
Seoul, Korea, Republic of
Contact: Dong-Bin Kim, M.D.            
Yeouido St.Mary Hospital Recruiting
Seoul, Korea, Republic of
Contact: Chul-Soo Park, M.D.            
Seoul St.Mary's Hospital Recruiting
Seoul, Korea, Republic of, 137-701
Sub-Investigator: Kiyuk Chang, M.D.            
Principal Investigator: Wook Sung Chung, M.D.            
Sub-Investigator: Pum Joon Kim, M.D.            
Sub-Investigator: Hun Jun Park, M.D.            
Sponsors and Collaborators
The Catholic University of Korea
Seoul St. Mary's Hospital
Yeouido St.Mary's Hospital
UiJeungbu St.Mary's Hospital
Bucheon St.Mary's Hospital
St.Paul's Hospital, Korea
Incheon St.Mary's Hospital
St.Vincent's Hospital of Korea
Daejeon St.Mary's Hospital
Investigators
Study Chair: Ki-Bae Seung, M.D.,PhD Seoul St. Mary's Hospital
  More Information

Additional Information:
web based registry  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ki-Bae Seung, Seoul St.Mary's Hospital
ClinicalTrials.gov Identifier: NCT01239914     History of Changes
Other Study ID Numbers: COACT
Study First Received: November 12, 2010
Last Updated: August 24, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by The Catholic University of Korea:
drug eluting stent
coronary artery disease
Korean registry

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013