Coronary Artery Disease, Myocardial Infarction
Conditions
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.
Interventions
PROCEDUREIRA stenting in culprit lesion only
stenting
PROCEDUREIRA stenting
Complete IRA revascularization
Sponsors
Fundacja Ośrodek Badań Medycznych
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade) | 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
| Measure | Time frame | Description |
|---|---|---|
| Clinical major ischemic events | 12-months | 1. Death at 12-month clinical follow-up 2. Stent thrombosis at 12-month follow-up according to ARC definition 3. reMI at 12 months 4. urgent TVR at 12 months |
| Adverse events and complications during hospital stay | during patient index hospitalization (up to 7 days) | 1. Immediate in-hospital angiographic complications (at least one or more of the following: distal embolisation, no-reflow, slow-flow, acute coronary artery occlusion,artery perforation, tamponade, dissection type B and above) 2. urgent in-hospital Target Vessel Revascularization (PCI and/or CABG - coronary artery bypass graft) |
Countries
Poland, Slovenia
Outcome results
None listed