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

Incheon-Bucheon Cohort of Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-segment Elevation Myocardial Infarction

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: Procedure: STEMI treated with primary PCI

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
• Enrollment (Actual): 1537

Contacts and Locations

Study Locations

• Korea, Republic of
  • Bucheon, Korea, Republic of
    • Sejong General Hospital
  • Bucheon, Korea, Republic of
    • Soon Chun Hyang University Bucheon Hospital
  • Incheon, Korea, Republic of
    • Inha University Hospital
  • Incheon, Korea, Republic of
    • Gachon University Gil Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
STEMI treated with primary PCI; Patients diagnosed with acute ST-segment elevation myocardial infarction and treated with primary percutaneous coronary intervention were consecutively registered.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACCE	Major adverse cardiac and cerebrovascular event (MACCE), defined as the composite of all-cause death, non-fatal myocardial infarction and non-fatal stroke	Within the 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
All-cause death	Within the 1 year
Non-fatal myocardial infarction	Within the 1 year
Non-fatal stroke	Within the 1 year
Ischemic-driven revascularization	Within the 1 year
Admission for heart failure	Within the 1 year

Collaborators and Investigators

• Sponsor: Gachon University Gil Medical Center
• Collaborators: Soon Chun Hyang University; Sejong General Hospital; Inha University Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: June 15, 2016
• First Submitted That Met QC Criteria: June 15, 2016
• First Posted (ESTIMATE): June 17, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): June 17, 2016
• Last Update Submitted That Met QC Criteria: June 15, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: ST-segment elevation myocardial infarction; Clinical outcomes; Primary percutaneous coronary intervention
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: INTERSTELLAR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Study Data/Documents

1. Clinical Study Report
   Information identifier: INTERSTELLAR-Stature
   Information comments: Relation of Stature to Outcomes in Korean Patients Undergoing Primary Percutaneous Coronary Intervention for Acute ST-Elevation Myocardial Infarction