Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Enrollment
- 1
- Locations
- 10
- Primary Endpoint
- ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)
Study Overview
Brief Summary
CORAMI trial is a prospective, international, multicenter randomized study which will be performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary intervention) duty and patient enrollment will continue for 18 months (October 2010 - March 2012).The aim of the study is to compare strategy of complete vs target lesion-only primary PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.
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
- •diagnosis of STEMI (according to ESC 2007 definition)
- •Chest pain onset <12 hours
- •signed informed consent
- •Presence of two critical lesions requiring PCI in IRA (LAD - left anterior descending, Cx - circumflex, RCA - right coronary artery)
- •Target/culprit lesion which requires immediate stenting (>50 - 100%) and second critical lesion (70-90%) with TIMI 3 flow after PCI of the 1st target/culprit lesion
- •Over 18 years of age
- •IRA diameter ≥ 2.5 mm
Exclusion Criteria
- •Terminal illness with life expectancy less <1 year or active cancer disease - Pregnancy or possibility of pregnancy
- •Second critical lesion in IRA >90% or occlusion
- •Contraindications to PCI or/and stent implantation
- •Contraindications to DES stent implantation
- •Lesion diameters unsuitable for intended stent platform
- •Active bleeding or coagulopathy
- •Patient in cardiogenic shock (<90mmHg SBP and/or requiring IABP - intraaortic balloon pump - or vasopressors) - Killip 4 class
- •Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
- •No future patient cooperation expected
- •Patient is participating in another clinical study
Arms & Interventions
Culprit lesion IRA Revascularization
Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
Intervention: IRA stenting in culprit lesion only (Procedure)
Complete IRA revascularization
Primary PCI of culprit lesion in IRA with DES stent
Intervention: IRA stenting (Procedure)
Outcomes
Primary Outcomes
ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)
Time Frame: in-hospital directly after PCI
This is a combined end-point of ST - segment resolution \>70% assessed directly after PCI + MBG 3 assessed directly after PCI (assessments by ECG and QCA Corelab).
Secondary Outcomes
- Clinical major ischemic events(12-months)
- Adverse events and complications during hospital stay(during patient index hospitalization (up to 7 days))