Complete Infarct Related Artery Revascularization

NCT ID: NCT01218815

Last Updated: 2015-03-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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Conditions

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Myocardial Infarction Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Culprit lesion IRA Revascularization

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

Group Type EXPERIMENTAL

IRA stenting in culprit lesion only

Intervention Type PROCEDURE

stenting

Complete IRA revascularization

Primary PCI of culprit lesion in IRA with DES stent

Group Type ACTIVE_COMPARATOR

IRA stenting

Intervention Type PROCEDURE

Complete IRA revascularization

Interventions

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IRA stenting in culprit lesion only

stenting

Intervention Type PROCEDURE

IRA stenting

Complete IRA revascularization

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundacja Ośrodek Badań Medycznych

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dariusz Dudek, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny

Warsaw, Banacha 1a, Poland

Site Status

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

Krakow, Kraków, Poland

Site Status

Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ

Sanok, Podkarpackie Voivodeship, Poland

Site Status

SP ZZOZ Powiatowy Szpital Specjalistyczny

Stalowa Wola, Stalowa Wola, Poland

Site Status

Pracownia Hemodynamiki Szpital im. E. Szczeklika

Tarnów, Szpitalna 13, Poland

Site Status

Centrum Kardiologii Inwazyjnej GVM Carint

Ostrowiec Świętokrzyski, Szymanowskiego 11, Poland

Site Status

Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

Warsaw, Warszawa, Poland

Site Status

Centrum Kardiologii Inwazyjnej GVM Carint

Oświęcim, Wysokie Brzegi 4, Poland

Site Status

Department of Interventional Cardiology, Jagiellonian University Medical College

Krakow, , Poland

Site Status

Departament of Cardiology, University Hospital, Ljubljana

Ljubljana, Ljubljana, Slovenia

Site Status

Countries

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Poland Slovenia

Other Identifiers

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3.0/2010

Identifier Type: -

Identifier Source: org_study_id

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