Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction (CORAMIreg)

Fundacja Ośrodek Badań Medycznych

Status

Completed

Conditions

Myocardial Infarction

Treatments

Device: Primary PCI of culprit lesion in IRA with drug eluting stent (DES)

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

Study type

Observational

Funder types

Other

Identifiers

NCT01642784

2.0, 2011-11-24

Details and patient eligibility

About

Objective of this registry study is to compare strategy of complete vs. target lesion-only primary PCI (percutaneous coronary intervention) in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.

Full description

CORAMI is a registry study addressing the issue of complete vs culprit-only PCI within infarct related artery in patients with ST-elevation and non-ST elevation myocardial infarction treated with interventional procedures.

The main objectives of the study include:

gathering data on patients with at least two independent critical stenotic lesions in IRA (one of which is the culprit lesion) during index primary PCI for STEMI or NSTEMI (prevalence, characteristic, predisposing factors).
comparing chosen treatment strategies for multiple lesion IRA
comparison of complete vs. target lesion-only PCI in IRA in acute MI (myocardial infarction) patients.

The study clinical hypothesis is that stenting single critical - culprit lesion in multi-lesion IRA in MI patients during index PCI procedure is superior to stenting all critical lesions in IRA in terms of early treatment result and might be associated with less frequent periprocedural angiographic complications.

H0: The efficacy in terms of early treatment result of stenting one critical - culprit lesion in multilesions IRA in acute MI patients is less or equal to efficacy of stenting all critical lesions in IRA.

H1: The efficacy in terms of early treatment result of stenting one critical - culprit lesion in multilesions IRA in acute MI patients is greater than efficacy of stenting all critical lesions in IRA.

CORAMI Registry is a prospective, international (Poland, Slovenia), multicenter observational study with retrospective chart review which will be performed in experienced invasive facility centres with 24/7 PCI duty and continuous patient enrollment for 18 months (January 2011 - June 2012).

This study will collect data on all consecutive patients with STEMI and NSTEMI undergoing immediate coronary angiography which demonstrated at least two independent (requiring two stent platforms) critical lesions in infarct related artery (one of which is considered as target/culprit lesion that have caused the myocardial infarction and requires immediate PCI). Patients will be treated (multiple or single lesion stenting) according to local standard and operator's decision. Patient follow up phone call and/or visit (according to local protocols) will be performed at 12 months from enrollment if applicable by local standards.

Enrollment

100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of STEMI or NSTEMI (according to ESC 2007 definition)
Over 18 years of age
Presence of two critical lesions requiring PCI in IRA (LAD (left anterior descending), Cx (circumflex), RCA (right coronary artery)):
1. Target/culprit lesion which requires immediate stenting (>50 - 100%) and
2. Second critical lesion (70-90%).

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
Con-current participation in another clinical study that did not meet its primary end-point