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

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

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.

Study Overview

• Status: Completed
• Conditions: Myocardial Infarction
• Intervention / Treatment: 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

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Poland
  • Kraków, Poland, 30-693
    • Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
  • Ostrowiec Swietokrzyski, Poland, 27-400
    • Centrum Kardiologii Inwazyjnej GVM Carint
  • Oświecim, Poland, 32-600
    • Centrum Kardiologii Inwazyjnej GVM Carint
  • Pinczow, Poland
    • Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
  • Sanok, Poland, 38-500
    • Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
  • Tarnów, Poland, 33-100
    • Pracownia Hemodynamiki Szpital im. E. Szczeklika
  • Warszawa, Poland, 02-097
    • I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
• Slovenia
  • Ljubljana, Slovenia
    • Departament of Cardiology, University Hospital, Ljubljana

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Study population will comprise of approx. 200 patients (males and females) with the diagnosis of STEMI or NSTEMI and at least two independent 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 enrolled to the registry must meet all the eligibility criteria.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Culprit lesion IRA revascularization	Device: Primary PCI of culprit lesion in IRA with drug eluting stent (DES); Primary PCI of culprit lesion in IRA with drug eluting stent (DES)
Complete IRA revascularization	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Death	Death rates at 12-month clinical follow-up	At 12 months
Stent thrombosis	Rates of stent thrombosis at 12-month follow-up according to ARC definition	At 12 months
reMI (repeat myocardial infarctions)	Rates of reMI at 12 months	At 12 months
urgent TVR (target vessel revascularization) at 12 months	Rates of urgent TVR at 12 months	12 months and at 12 months
Planned TVR	Rates of planned TVR (PCI + CABG) at 12 months	At 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Angiographic complications	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)	During hospitalization
Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft))	Urgent in-hospital Target Vessel Revascularization (PCI and/or CABG)	During hospitalization and at 12 months
Complete contrast dose in ml	Complete contrast dose in ml	During hospitalization and at 12 months
Complete radiation dose in mGy	Complete radiation dose in mGy	During hospitalization and at 12 months

Collaborators and Investigators

• Sponsor: Fundacja Ośrodek Badań Medycznych
• Investigators: Principal Investigator: Bogdan Januś, MD, PhD, Pracownia Hemodynamiki Szpital im. E. Szczeklika

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: June 25, 2012
• First Submitted That Met QC Criteria: July 15, 2012
• First Posted (ESTIMATE): July 17, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 3, 2013
• Last Update Submitted That Met QC Criteria: July 2, 2013
• Last Verified: July 1, 2013

More Information

Terms related to this study

• Keywords: STEMI; stents; NSTEMI; revascularization
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction
• Other Study ID Numbers: 2.0, 2011-11-24