Complete Infarct Related Artery Revascularization

Coronary Artery Disease Clinical Trial

— CORAMI  

Official title:

Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01218815
• Other study ID #: 3.0/2010
• Status: Terminated
• Phase: N/A
• First received: October 1, 2010
• Last updated: March 5, 2015
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: March 2015
• Source: Fundacja Osrodek Badan Medycznych
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Procedure:
• IRA stenting in culprit lesion only
stenting
• IRA stenting
Complete IRA revascularization

Locations

Country	Name	City	State
Poland	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	Centrum Kardiologii Inwazyjnej GVM Carint	Ostrowiec Swietokrzyski	Szymanowskiego 11
Poland	Centrum Kardiologii Inwazyjnej GVM Carint	Oswiecim	Wysokie Brzegi 4
Poland	Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ	Sanok	Podkarpackie
Poland	SP ZZOZ Powiatowy Szpital Specjalistyczny	Stalowa Wola
Poland	Pracownia Hemodynamiki Szpital im. E. Szczeklika	Tarnow	Szpitalna 13
Poland	I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny	Warszawa	Banacha 1a
Poland	Instytut Kardiologii im. Prymasa Tysiaclecia Stefana Kardynala Wyszynskiego	Warszawa
Slovenia	Departament of Cardiology, University Hospital, Ljubljana	Ljubljana

Sponsors (1)

Lead Sponsor	Collaborator
Fundacja Osrodek Badan Medycznych

Countries where clinical trial is conducted

Poland,  Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	in-hospital directly after PCI	No
Secondary	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	12-months	No
Secondary	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)	during patient index hospitalization (up to 7 days)	Yes

External Links

•   Department of Interventional Cardiology, Jagiellonian University Medical College