Complete Infarct Related Artery Revascularization (CORAMI)

This study has been terminated.
(Due to very low enrollment rate the study was terminated.)
Sponsor:
Information provided by (Responsible Party):
Fundacja Ośrodek Badań Medycznych
ClinicalTrials.gov Identifier:
NCT01218815
First received: October 1, 2010
Last updated: November 9, 2011
Last verified: November 2011
  Purpose

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01218815

Locations
Poland
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
Slovenia
Departament of Cardiology, University Hospital, Ljubljana
Ljubljana, Slovenia, 1000
Sponsors and Collaborators
Fundacja Ośrodek Badań Medycznych
Investigators
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
ClinicalTrials.gov 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
Infarction
Myocardial Infarction
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on July 23, 2014