NCT00942500CompletedNot Applicable
Effects of Postconditioning On Myocardial Reperfusion in Patients With ST-segment Elevation Myocardial Infarction
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 700
- Locations
- 1
- Primary Endpoint
- The dichotomous rate of complete ST-segment resolution (STR)
Study Overview
Brief Summary
The purpose of this study is to investigate the effects of postconditioning on myocardial reperfusion in patients with ST-segment elevation myocardial infarction.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •General Inclusion Criteria
- •Subject must be at least 18 years of age.
- •Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving postconditioning and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure
- •Diagnosis of STEMI
- •presence of chest pain for more than 30 minutes but less than 12 hours after symptom onset
- •ST-segment elevation more than 1 mm in at least 2 contiguous leads
- •Angiographic Inclusion Criteria
- •Target lesion(s) must be located in a native coronary artery
- •Target lesion(s) must be amenable for percutaneous coronary intervention
- •TIMI flow grade of infarct related arteries <2
Exclusion Criteria
- •Patients with hemodynamic instability or those with cardiogenic shock
- •Target lesion is located in left main stem
- •Rescue PCI after thrombolysis or facilitated PCI
- •Non-cardiac co-morbid conditions are present with life expectancy <1 year or that may result in protocol non-compliance (per site investigator's medical judgment)
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
Arms & Interventions
Post-conditioning
Experimental
Intervention: Post-conditioning (Procedure)
Conventional primary PCI
No Intervention
Outcomes
Primary Outcomes
The dichotomous rate of complete ST-segment resolution (STR)
Time Frame: at 30 minutes after final contrast injection
Secondary Outcomes
- Myocardial blush grade(within 10 minutes after PCI)
- Thrombolysis in Myocardial Infarction (TIMI) flow grade(within 10 minutes after PCI)
- Angiographic no-reflow(during PCI)
- All death(at 30 days and 1 year)
- Stent thrombosis(at 30 days and 1 year)
- Cardiac death(at 30 days and 1 year)
- Myocardial infarction(at 30 days and 1 year)
- Severe heart failure(at 30 days and 1 year)
- Target vessel revascularization (TVR)(at 30 days and 1 year)
- Composite of death, MI, severe heart failure, or stent thrombosis(at 30 days and 1 year)
Investigators
Hyeon-Cheol Gwon
Professor
Samsung Medical Center
Study Sites (1)
Loading locations...
Similar Trials
Completed
Phase 4
Pharmacological Postconditioning to Reduce Infarct Size Following Primary PCIMyocardial InfarctionNCT00835848Rigshospitalet, Denmark100
Completed
Not Applicable
Effect of postconditioning on cardiac protection in children undergoing tetralogy repairCirculatory SystemInfants and children with Tetralogy undergoing radical repairISRCTN36248338Xiang Ya Hospital (China)30
Completed
Not Applicable
Ischemic Postconditioning in Cardiac SurgeryCardiac SurgeryNCT01813968Oslo University Hospital209
Completed
Phase 1
Positive Effect of Ischemic Postconditioning During Acute Myocardial InfarctionAcute Myocardial InfarctionNCT00333320French Cardiology Society46
Completed
Not Applicable
Analysis of the Efficacy of Cardiac Ischemic Postconditioning With New Clinical End-points Using Novel BiomarkersAcute Myocardial Infarction With ST ElevationNCT04824716Peter Ferdinandy100