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Incheon-Bucheon Cohort of Patients Undergoing Primary PCI for Acute STEMI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02804958
Recruitment Status : Completed
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Collaborators:
Soon Chun Hyang University
Sejong General Hospital
Inha University Hospital
Information provided by (Responsible Party):
Woong Chol Kang, Gachon University Gil Medical Center

Tracking Information
First Submitted Date June 15, 2016
First Posted Date June 17, 2016
Last Update Posted Date June 17, 2016
Study Start Date December 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 15, 2016)
MACCE [ Time Frame: Within the 1 year ]
Major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, non-fatal myocardial infarction and non-fatal stroke
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 15, 2016)
  • All-cause death [ Time Frame: Within the 1 year ]
  • Non-fatal myocardial infarction [ Time Frame: Within the 1 year ]
  • Non-fatal stroke [ Time Frame: Within the 1 year ]
  • Ischemic-driven revascularization [ Time Frame: Within the 1 year ]
  • Admission for heart failure [ Time Frame: Within the 1 year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Incheon-Bucheon Cohort of Patients Undergoing Primary PCI for Acute STEMI
Official Title Incheon-Bucheon Cohort of Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-segment Elevation Myocardial Infarction
Brief Summary INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction undergoing primary percutaneous coronary intervention at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014.
Detailed Description

INcheon-Bucheon cohorT of patients undERgoing primary percutaneous coronary intervention for acute ST-ELevation myocardiaL infARction (INTERSTELLAR) registry is a retrospective, observational, 4-regional-hospital based registry reflecting current practices of management, risk factors, and clinical outcomes in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) at cities of Incheon and Bucheon located in the mid-western part of the Korean peninsula between 2007 and 2014. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.

Demographic data, cardiovascular risk factors, laboratory data and clinical follow-up data were collected. Baseline blood test was obtained and recorded as part of the routine care for patients who visited the emergency room for chest pain and in whom acute coronary syndrome was suspected. Standard medical management was provided by responsible physicians.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients diagnosed with acute ST-segment elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) were consecutively registered. Diagnosis of acute STEMI was based on clinical data findings including typical symptoms, 12-lead electrocardiography, and blood test. Decisions regarding primary PCI were made by at least 2 attending cardiologists at the time of presentation.
Condition Myocardial Infarction
Intervention Procedure: STEMI treated with primary PCI
Primary percutaneous coronary intervention was performed according to the current standard guidelines. Coronary angiography was performed using standard techniques. The use of thrombectomy devices, intravascular ultrasound, intra-aortic balloon pump, and percutaneous cardiopulmonary support was up to the operator.
Study Groups/Cohorts STEMI treated with primary PCI
Patients diagnosed with acute ST-segment elevation myocardial infarction and treated with primary percutaneous coronary intervention were consecutively registered.
Intervention: Procedure: STEMI treated with primary PCI
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 Completed
Actual Enrollment
 (submitted: June 15, 2016)
1537
Original Actual Enrollment Same as current
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients diagnosed with acute ST-segment elevation myocardial infarction
  • Patients treated with primary percutaneous coronary intervention

Exclusion Criteria:

  • Patients diagnosed with Non-ST-segment elevation acute coronary syndrome
  • Patients treated with thrombolytic therapy
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02804958
Other Study ID Numbers INTERSTELLAR
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Woong Chol Kang, Gachon University Gil Medical Center
Study Sponsor Gachon University Gil Medical Center
Collaborators
  • Soon Chun Hyang University
  • Sejong General Hospital
  • Inha University Hospital
Investigators
Principal Investigator: Woong Chol Kang, MD Gachon University Gil Medical Center
PRS Account Gachon University Gil Medical Center
Verification Date June 2016