Clinical trial NCT01218815: Complete Infarct Related Artery Revascularization
Official title: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myocardial Infarction
Coronary Artery Disease
Lead sponsor: Fundacja Ośrodek Badań Medycznych
Sponsor class: OTHER
First posted: 2010-10-11
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)
timeFrame: in-hospital directly after PCI
Secondary outcomes:
measure: Clinical major ischemic events
timeFrame: 12-months
measure: Adverse events and complications during hospital stay
timeFrame: during patient index hospitalization (up to 7 days)
Other outcomes:
Locations:
city: Warszawa
country: Poland
facility: I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
state: Banacha 1a
city: Sanok
country: Poland
facility: Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
state: Podkarpackie
city: Tarnow
country: Poland
facility: Pracownia Hemodynamiki Szpital im. E. Szczeklika
state: Szpitalna 13
city: Ostrowiec Swietokrzyski
country: Poland
facility: Centrum Kardiologii Inwazyjnej GVM Carint
state: Szymanowskiego 11
city: Oswiecim
country: Poland
facility: Centrum Kardiologii Inwazyjnej GVM Carint
state: Wysokie Brzegi 4
city: Krakow
country: Poland
facility: Department of Interventional Cardiology, Jagiellonian University Medical College
city: Kraków
country: Poland
facility: Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
city: Stalowa Wola
country: Poland
facility: SP ZZOZ Powiatowy Szpital Specjalistyczny
city: Warszawa
country: Poland
facility: Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego
city: Ljubljana
country: Slovenia
facility: Departament of Cardiology, University Hospital, Ljubljana
Study officials:
affiliation: Department of Interventional Cardiology, Jagiellonian University Medical College in Krakow, Poland
name: Dariusz Dudek, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: