Complete Infarct Related Artery Revascularization

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01218815
• Date of registration: 01/10/2010
• Primary sponsor: Fundacja Osrodek Badan Medycznych
• Public title: Complete Infarct Related Artery Revascularization CORAMI
• Scientific title: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial
• Date of first enrolment: October 2010
• Target sample size: 1
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT01218815
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Poland, Slovenia

Contacts

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

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Myocardial Infarction

Intervention(s)

Procedure: IRA stenting

Procedure: IRA stenting in culprit lesion only

Primary Outcome(s)

ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade) [Time Frame: in-hospital directly after PCI]

Secondary Outcome(s)

Adverse events and complications during hospital stay [Time Frame: during patient index hospitalization (up to 7 days)]

Clinical major ischemic events [Time Frame: 12-months]

Secondary ID(s)

3.0/2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors