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Asan Medical Center Myocardial Infarction Registry (Asan-MI)

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ClinicalTrials.gov Identifier: NCT03412435
Recruitment Status : Recruiting
First Posted : January 26, 2018
Last Update Posted : June 23, 2021
Sponsor:
Collaborator:
CardioVascular Research Foundation, Korea
Information provided by (Responsible Party):
Seung-Jung Park, Asan Medical Center

Tracking Information
First Submitted Date January 21, 2018
First Posted Date January 26, 2018
Last Update Posted Date June 23, 2021
Actual Study Start Date April 27, 2018
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 21, 2018)
A composite event of all-cause death, non-fatal myocardial infarction and repeat revascularization [ Time Frame: 1 year ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: January 29, 2018)
  • All cause death [ Time Frame: 5 year ]
  • Cardiac death [ Time Frame: 5 year ]
  • Myocardial infarction [ Time Frame: 5 year ]
  • A composite event of all-cause death and myocardial infarction [ Time Frame: 5 year ]
  • A composite event of cardiac death and myocardial infarction [ Time Frame: 5 year ]
  • Repeat revascularization [ Time Frame: 5 year ]
  • Stent thrombosis [ Time Frame: 5 year ]
    according to Academic Research Consortium (ARC) criteria
  • Stroke [ Time Frame: 5 year ]
    A stroke or cerebrovascular accident with loss of neurological function caused by an ischemic or hemorrhagic event with residual symptoms at least 24 hours after onset or leading to death.
  • Procedure success [ Time Frame: 7 days ]
    Successful percutaneous coronary intervention at the intended target lesion with final instant residual stenosis of less than 30% by quantitative coronary angiography (QCA) and no event of death or Q wave myocardial infarction or urgent revascularization during hospitalization.
  • Surgery success [ Time Frame: 7 days ]
    Successful surgery defines as no event of death or Q wave myocardial infarction or urgent revascularization during hospitalization.
Original Secondary Outcome Measures
 (submitted: January 21, 2018)
  • All cause death [ Time Frame: 5 year ]
  • Cardiac death [ Time Frame: 5 year ]
  • Myocardial infarction [ Time Frame: 5 year ]
  • A composite event of all-cause death and myocardial infarction [ Time Frame: 5 year ]
  • A composite event of cardiac death and myocardial infarction [ Time Frame: 5 year ]
  • Repeat revascularization [ Time Frame: 5 year ]
  • Stent thrombosis [ Time Frame: 5 year ]
    according to Academic Research Consortium (ARC) criteria
  • Stroke [ Time Frame: 5 year ]
  • Procedure success [ Time Frame: 7 days ]
    Successful percutaneous coronary intervention at the intended target lesion with final instant residual stenosis of less than 30% by quantitative coronary angiography (QCA) and no event of death or Q wave myocardial infarction or urgent revascularization during hospitalization.
  • Surgery success [ Time Frame: 7 days ]
    Successful surgery defines as no event of death or Q wave myocardial infarction or urgent revascularization during hospitalization.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Asan Medical Center Myocardial Infarction Registry
Official Title Asan Medical Center Myocardial Infarction Registry
Brief Summary This study evaluates long-term outcome of patients diagnosed as acute myocardial infarction and treated with medication, coronary artery bypass surgery and percutaneous coronary intervention in Asan medical center, Korea.
Detailed Description This study will collect 3000 cases retrospectively and 2000 cases prospectively.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population All consecutive acute myocardial infarction patients diagnosed through coronary angiography
Condition
  • Myocardial Infarction, Acute
  • Coronary Stenosis
Intervention Not Provided
Study Groups/Cohorts Myocardial infarction
diagnosed as acute myocardial infarction and treated with medical treatment, coronary artery bypass surgery and percutaneous coronary intervention.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 21, 2018)
5000
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2030
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All consecutive acute myocardial infarction patients diagnosed through coronary angiography
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Seung-jung Park, MD sjpark@amc.seoul.kr
Contact: Jung-hwa Lee, RN 82230104734 nurse9726@amc.seoul.kr
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03412435
Other Study ID Numbers AMCCV2018-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Seung-Jung Park, Asan Medical Center
Study Sponsor Seung-Jung Park
Collaborators CardioVascular Research Foundation, Korea
Investigators Not Provided
PRS Account Asan Medical Center
Verification Date June 2021