Complete Infarct Related Artery Revascularization

NCT01218815 | Terminated

• 1 other identifier: 3.0/2010
• Study Type: interventional
• Target: 1
• Locations: 2 countries
• Sites: 10

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.

Conditions

Myocardial Infarction; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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).

  in-hospital directly after PCI

Secondary Outcomes (2)

• Clinical major ischemic events

  12-months

• Adverse events and complications during hospital stay

  during patient index hospitalization (up to 7 days)

Study Arms (2)

Culprit lesion IRA Revascularization

EXPERIMENTAL

Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES

Procedure: IRA stenting in culprit lesion only

Complete IRA revascularization

ACTIVE COMPARATOR

Primary PCI of culprit lesion in IRA with DES stent

Procedure: IRA stenting

Interventions

IRA stenting in culprit lesion only PROCEDURE

stenting

Culprit lesion IRA Revascularization

IRA stenting PROCEDURE

Complete IRA revascularization

Complete IRA revascularization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacja Ośrodek Badań Medycznych: lead

Study Sites (10)

I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny

Warsaw, Banacha 1a, 02-097, Poland

Location

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

Krakow, Kraków, 30-693, Poland

Location

Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ

Sanok, Podkarpackie Voivodeship, 38-500, Poland

Location

SP ZZOZ Powiatowy Szpital Specjalistyczny

Stalowa Wola, Stalowa Wola, 37-450, Poland

Location

Pracownia Hemodynamiki Szpital im. E. Szczeklika

Tarnów, Szpitalna 13, 33-100, Poland

Location

Centrum Kardiologii Inwazyjnej GVM Carint

Ostrowiec Świętokrzyski, Szymanowskiego 11, 27-400, Poland

Location

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

Warsaw, Warszawa, 04-628, Poland

Location

Centrum Kardiologii Inwazyjnej GVM Carint

Oświęcim, Wysokie Brzegi 4, 32-600, Poland

Location

Department of Interventional Cardiology, Jagiellonian University Medical College

Krakow, Poland

Location

Departament of Cardiology, University Hospital, Ljubljana

Ljubljana, Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Myocardial Infarction; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Dariusz Dudek, MD, PhD

  Department of Interventional Cardiology, Jagiellonian University Medical College in Krakow, Poland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2010
• First Posted: October 11, 2010
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: March 6, 2015

Record last verified: 2015-03

Locations

SL (1); PL (9)