Complete Infarct Related Artery Revascularization

Not Applicable

Terminated

• Conditions: Coronary Artery Disease; Myocardial Infarction

• 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

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

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

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

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

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

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

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

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