Complete Infarct Related Artery Revascularization (CORAMI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01218815
Recruitment Status : Terminated (Due to very low enrollment rate the study was terminated.)
First Posted : October 11, 2010
Last Update Posted : March 6, 2015
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Myocardial Infarction Coronary Artery Disease Procedure: IRA stenting in culprit lesion only Procedure: IRA stenting Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial
Study Start Date : October 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

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
Active Comparator: Complete IRA revascularization
Primary PCI of culprit lesion in IRA with DES stent
Procedure: IRA stenting
Complete IRA revascularization

Primary Outcome Measures :
  1. 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).

Secondary Outcome Measures :
  1. 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

  2. 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)

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01218815

I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
Warszawa, Banacha 1a, Poland, 02-097
Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
Sanok, Podkarpackie, Poland, 38-500
Pracownia Hemodynamiki Szpital im. E. Szczeklika
Tarnow, Szpitalna 13, Poland, 33-100
Centrum Kardiologii Inwazyjnej GVM Carint
Ostrowiec Swietokrzyski, Szymanowskiego 11, Poland, 27-400
Centrum Kardiologii Inwazyjnej GVM Carint
Oswiecim, Wysokie Brzegi 4, Poland, 32-600
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, 30-693
SP ZZOZ Powiatowy Szpital Specjalistyczny
Stalowa Wola, Poland, 37-450
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
Warszawa, Poland, 04-628
Departament of Cardiology, University Hospital, Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Fundacja Ośrodek Badań Medycznych
Principal Investigator: Dariusz Dudek, MD, PhD Department of Interventional Cardiology, Jagiellonian University Medical College in Krakow, Poland

Responsible Party: Fundacja Ośrodek Badań Medycznych Identifier: NCT01218815     History of Changes
Other Study ID Numbers: 3.0/2010
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: March 6, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases