Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction

Myocardial Infarction Clinical Trial

— CORAMIreg  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01642784
• Other study ID #: 2.0, 2011-11-24
• Status: Completed
• Phase: N/A
• First received: June 25, 2012
• Last updated: July 2, 2013
• Start date: November 2011
• Est. completion date: July 2013

Study information

• Verified date: July 2013
• Source: Fundacja Osrodek Badan Medycznych
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsPoland: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

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)
• 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

Locations

Country	Name	City	State
Poland	Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.	Kraków
Poland	Centrum Kardiologii Inwazyjnej GVM Carint	Ostrowiec Swietokrzyski
Poland	Centrum Kardiologii Inwazyjnej GVM Carint	Oswiecim
Poland	Oddzial Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pinczowie	Pinczow
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	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	Death	Death rates at 12-month clinical follow-up	At 12 months	Yes
Primary	Stent thrombosis	Rates of stent thrombosis at 12-month follow-up according to ARC definition	At 12 months	Yes
Primary	reMI (repeat myocardial infarctions)	Rates of reMI at 12 months	At 12 months	Yes
Primary	urgent TVR (target vessel revascularization) at 12 months	Rates of urgent TVR at 12 months	12 months and at 12 months	Yes
Primary	Planned TVR	Rates of planned TVR (PCI + CABG) at 12 months	At 12 months	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Complete contrast dose in ml	Complete contrast dose in ml	During hospitalization and at 12 months	No
Secondary	Complete radiation dose in mGy	Complete radiation dose in mGy	During hospitalization and at 12 months	No