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Complete Infarct Related Artery Revascularization (CORAMI)

Primary Purpose

Myocardial Infarction, Coronary Artery Disease

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
IRA stenting in culprit lesion only
IRA stenting
Sponsored by
Fundacja Ośrodek Badań Medycznych
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myocardial Infarction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
  • Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
  • Pracownia Hemodynamiki Szpital im. E. Szczeklika
  • Centrum Kardiologii Inwazyjnej GVM Carint
  • Centrum Kardiologii Inwazyjnej GVM Carint
  • Department of Interventional Cardiology, Jagiellonian University Medical College
  • Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
  • SP ZZOZ Powiatowy Szpital Specjalistyczny
  • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
  • Departament of Cardiology, University Hospital, Ljubljana

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Culprit lesion IRA Revascularization

Complete IRA revascularization

Arm Description

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

Primary PCI of culprit lesion in IRA with DES stent

Outcomes

Primary Outcome Measures

ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)
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
Death at 12-month clinical follow-up Stent thrombosis at 12-month follow-up according to ARC definition reMI at 12 months urgent TVR at 12 months
Adverse events and complications during hospital stay
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) urgent in-hospital Target Vessel Revascularization (PCI and/or CABG - coronary artery bypass graft)

Full Information

First Posted
October 1, 2010
Last Updated
March 5, 2015
Sponsor
Fundacja Ośrodek Badań Medycznych
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1. Study Identification

Unique Protocol Identification Number
NCT01218815
Brief Title
Complete Infarct Related Artery Revascularization
Acronym
CORAMI
Official Title
Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to very low enrollment rate the study was terminated.
Study Start Date
October 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundacja Ośrodek Badań Medycznych

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Culprit lesion IRA Revascularization
Arm Type
Experimental
Arm Description
Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
Arm Title
Complete IRA revascularization
Arm Type
Active Comparator
Arm Description
Primary PCI of culprit lesion in IRA with DES stent
Intervention Type
Procedure
Intervention Name(s)
IRA stenting in culprit lesion only
Intervention Description
stenting
Intervention Type
Procedure
Intervention Name(s)
IRA stenting
Intervention Description
Complete IRA revascularization
Primary Outcome Measure Information:
Title
ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)
Description
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).
Time Frame
in-hospital directly after PCI
Secondary Outcome Measure Information:
Title
Clinical major ischemic events
Description
Death at 12-month clinical follow-up Stent thrombosis at 12-month follow-up according to ARC definition reMI at 12 months urgent TVR at 12 months
Time Frame
12-months
Title
Adverse events and complications during hospital stay
Description
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) urgent in-hospital Target Vessel Revascularization (PCI and/or CABG - coronary artery bypass graft)
Time Frame
during patient index hospitalization (up to 7 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dariusz Dudek, MD, PhD
Organizational Affiliation
Department of Interventional Cardiology, Jagiellonian University Medical College in Krakow, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
City
Warszawa
State/Province
Banacha 1a
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
City
Sanok
State/Province
Podkarpackie
ZIP/Postal Code
38-500
Country
Poland
Facility Name
Pracownia Hemodynamiki Szpital im. E. Szczeklika
City
Tarnow
State/Province
Szpitalna 13
ZIP/Postal Code
33-100
Country
Poland
Facility Name
Centrum Kardiologii Inwazyjnej GVM Carint
City
Ostrowiec Swietokrzyski
State/Province
Szymanowskiego 11
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Centrum Kardiologii Inwazyjnej GVM Carint
City
Oswiecim
State/Province
Wysokie Brzegi 4
ZIP/Postal Code
32-600
Country
Poland
Facility Name
Department of Interventional Cardiology, Jagiellonian University Medical College
City
Krakow
Country
Poland
Facility Name
Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
City
Kraków
ZIP/Postal Code
30-693
Country
Poland
Facility Name
SP ZZOZ Powiatowy Szpital Specjalistyczny
City
Stalowa Wola
ZIP/Postal Code
37-450
Country
Poland
Facility Name
Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
City
Warszawa
ZIP/Postal Code
04-628
Country
Poland
Facility Name
Departament of Cardiology, University Hospital, Ljubljana
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia

12. IPD Sharing Statement

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Complete Infarct Related Artery Revascularization

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