Complete Infarct Related Artery Revascularization (CORAMI)

March 5, 2015 updated by: Fundacja Ośrodek Badań Medycznych

Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Krakow, Poland
        • Department of Interventional Cardiology, Jagiellonian University Medical College
      • Kraków, Poland, 30-693
        • Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
      • Stalowa Wola, Poland, 37-450
        • SP ZZOZ Powiatowy Szpital Specjalistyczny
      • Warszawa, Poland, 04-628
        • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
    • Banacha 1a
      • Warszawa, Banacha 1a, Poland, 02-097
        • I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
    • Podkarpackie
      • Sanok, Podkarpackie, Poland, 38-500
        • Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
    • Szpitalna 13
      • Tarnow, Szpitalna 13, Poland, 33-100
        • Pracownia Hemodynamiki Szpital im. E. Szczeklika
    • Szymanowskiego 11
      • Ostrowiec Swietokrzyski, Szymanowskiego 11, Poland, 27-400
        • Centrum Kardiologii Inwazyjnej GVM Carint
    • Wysokie Brzegi 4
      • Oswiecim, Wysokie Brzegi 4, Poland, 32-600
        • Centrum Kardiologii Inwazyjnej GVM Carint
  • Slovenia
      • Ljubljana, Slovenia, 1000
        • Departament of Cardiology, University Hospital, Ljubljana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Procedure: IRA stenting in culprit lesion only
stenting
ACTIVE_COMPARATOR: Complete IRA revascularization
Primary PCI of culprit lesion in IRA with DES stent
Procedure: IRA stenting
Complete IRA revascularization

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)
Time Frame: 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).
in-hospital directly after PCI

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical major ischemic events
Time Frame: 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
12-months
Adverse events and complications during hospital stay
Time Frame: 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)
during patient index hospitalization (up to 7 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacja Ośrodek Badań Medycznych

Investigators

  • Principal Investigator: Dariusz Dudek, MD, PhD, Department of Interventional Cardiology, Jagiellonian University Medical College in Krakow, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2010

Primary Completion (ACTUAL)

October 1, 2011

Study Completion (ACTUAL)

October 1, 2011

Study Registration Dates

First Submitted

October 1, 2010

First Submitted That Met QC Criteria

October 8, 2010

First Posted (ESTIMATE)

October 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2015

Last Update Submitted That Met QC Criteria

March 5, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3.0/2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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