Complete Infarct Related Artery Revascularization

Not Applicable

Terminated

• Conditions: Coronary Artery Disease; Myocardial Infarction
• Interventions: Procedure: IRA stenting in culprit lesion only; Procedure: IRA stenting

• Registration Number: NCT01218815
• Lead Sponsor: Fundacja Ośrodek Badań Medycznych

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-01
• Study First Submitted QC: 2010-10-08
• Study First Posted: 2010-10-11
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-05
• Last Update Posted: 2015-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Culprit lesion IRA Revascularization	IRA stenting in culprit lesion only	Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
Complete IRA revascularization	IRA stenting	Primary PCI of culprit lesion in IRA with DES stent

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (9)

I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny; 🇵🇱 Warszawa, Banacha 1a, Poland

Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ; 🇵🇱 Sanok, Podkarpackie, Poland

Department of Interventional Cardiology, Jagiellonian University Medical College; 🇵🇱 Krakow, Poland

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego; 🇵🇱 Warszawa, Poland

Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.; 🇵🇱 Kraków, Poland

SP ZZOZ Powiatowy Szpital Specjalistyczny; 🇵🇱 Stalowa Wola, Poland

Centrum Kardiologii Inwazyjnej GVM Carint; 🇵🇱 Oswiecim, Wysokie Brzegi 4, Poland

Pracownia Hemodynamiki Szpital im. E. Szczeklika; 🇵🇱 Tarnow, Szpitalna 13, Poland

Departament of Cardiology, University Hospital, Ljubljana; 🇸🇮 Ljubljana, Slovenia