Complete Infarct Related Artery Revascularization

Fundacja Ośrodek Badań Medycznych1 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myocardial Infarction Coronary Artery Disease

Interventions

IRA stenting in culprit lesion onlyPROCEDURE

stenting

IRA stentingPROCEDURE

Complete IRA revascularization

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (10)

I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny

Warsaw, Banacha 1a, Poland

Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.

Krakow, Kraków, Poland

Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ

Sanok, Podkarpackie Voivodeship, Poland

Outcomes

Primary Outcomes

ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)

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).

Time frame: in-hospital directly after PCI

Secondary Outcomes

Clinical major ischemic events

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

Time frame: 12-months

Adverse events and complications during hospital stay

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)

Time frame: during patient index hospitalization (up to 7 days)

Data from ClinicalTrials.gov

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