Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction

NCT ID: NCT01642784

Last Updated: 2013-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-11-30
• Study Completion Date: 2013-07-31

Brief Summary

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.

Detailed 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:

1. 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).

2. comparing chosen treatment strategies for multiple lesion IRA

3. 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.

Conditions

Myocardial Infarction

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Culprit lesion IRA revascularization

Culprit lesion IRA revascularization

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

Intervention Type: DEVICE

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

Complete IRA revascularization

Complete IRA revascularization

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

Intervention Type: 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

Interventions

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

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

Intervention Type: 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

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundacja Ośrodek Badań Medycznych

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bogdan Januś, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pracownia Hemodynamiki Szpital im. E. Szczeklika

Locations

Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.

Krakow, , Poland

Centrum Kardiologii Inwazyjnej GVM Carint

Ostrowiec Świętokrzyski, , Poland

Centrum Kardiologii Inwazyjnej GVM Carint

Oświecim, , Poland

Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie

Pińczów, , Poland

Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ

Sanok, , Poland

Pracownia Hemodynamiki Szpital im. E. Szczeklika

Tarnów, , Poland

I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny

Warsaw, , Poland

Departament of Cardiology, University Hospital, Ljubljana

Ljubljana, , Slovenia

Countries

Poland; Slovenia

Other Identifiers

2.0, 2011-11-24

Identifier Type: -

Identifier Source: org_study_id