Complete Infarct Related Artery Revascularization (CORAMI)

This study has been terminated.
(Due to very low enrollment rate the study was terminated.)
Information provided by (Responsible Party):
Fundacja Ośrodek Badań Medycznych Identifier:
First received: October 1, 2010
Last updated: November 9, 2011
Last verified: November 2011

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 Intervention
Myocardial Infarction
Coronary Artery Disease
Procedure: IRA stenting in culprit lesion only
Procedure: IRA stenting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial

Resource links provided by NLM:

Further study details as provided by Fundacja Ośrodek Badań Medycznych:

Primary Outcome Measures:
  • ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade) [ Time Frame: in-hospital directly after PCI ] [ Designated as safety issue: No ]

    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:
  • Clinical major ischemic events [ Time Frame: 12-months ] [ Designated as safety issue: No ]
    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 [ Time Frame: during patient index hospitalization (up to 7 days) ] [ Designated as safety issue: Yes ]
    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)

Enrollment: 1
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT01218815

Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
Sanok, 800-lecia 26, Poland, 38-500
I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
Warszawa, Banacha 1a, Poland, 02-097
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
  More Information

Additional Information:
No publications provided

Responsible Party: Fundacja Ośrodek Badań Medycznych Identifier: NCT01218815     History of Changes
Other Study ID Numbers: 3.0/2010
Study First Received: October 1, 2010
Last Updated: November 9, 2011
Health Authority: Poland: Ministry of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Necrosis processed this record on April 17, 2014