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

Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02804958
• Other study ID #: INTERSTELLAR
• Status: Completed
• Phase: N/A
• First received: June 15, 2016
• Last updated: June 15, 2016
• Start date: December 2014
• Est. completion date: December 2015

Study information

• Verified date: June 2016
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1537
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infarction
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Sejong General Hospital	Bucheon
Korea, Republic of	Soon Chun Hyang University Bucheon Hospital	Bucheon
Korea, Republic of	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Inha University Hospital	Incheon

Sponsors (4)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center	Inha University Hospital, Sejong General Hospital, Soon Chun Hyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	All-cause death		Within the 1 year	Yes
Secondary	Non-fatal myocardial infarction		Within the 1 year	Yes
Secondary	Non-fatal stroke		Within the 1 year	Yes
Secondary	Ischemic-driven revascularization		Within the 1 year	Yes
Secondary	Admission for heart failure		Within the 1 year	Yes