Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction
- Conditions
- Myocardial Infarction
- Interventions
- 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
- Registration Number
- NCT01642784
- Lead Sponsor
- Fundacja Ośrodek Badań Medycznych
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
-
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)):
- Target/culprit lesion which requires immediate stenting (>50 - 100%) and
- Second critical lesion (70-90%).
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Culprit lesion IRA revascularization Primary PCI of culprit lesion in IRA with drug eluting stent (DES) Culprit lesion 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 Complete IRA revascularization
- Primary Outcome Measures
Name Time Method Death At 12 months Death rates at 12-month clinical follow-up
Stent thrombosis At 12 months Rates of stent thrombosis at 12-month follow-up according to ARC definition
reMI (repeat myocardial infarctions) At 12 months Rates of reMI at 12 months
urgent TVR (target vessel revascularization) at 12 months 12 months and at 12 months Rates of urgent TVR at 12 months
Planned TVR At 12 months Rates of planned TVR (PCI + CABG) at 12 months
- Secondary Outcome Measures
Name Time Method Angiographic complications During hospitalization 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)
Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft)) During hospitalization and at 12 months Urgent in-hospital Target Vessel Revascularization (PCI and/or CABG)
Complete contrast dose in ml During hospitalization and at 12 months Complete contrast dose in ml
Complete radiation dose in mGy During hospitalization and at 12 months Complete radiation dose in mGy
Trial Locations
- Locations (7)
Pracownia Hemodynamiki Szpital im. E. Szczeklika
🇵🇱Tarnów, Poland
Centrum Kardiologii Inwazyjnej GVM Carint
🇵🇱Oświecim, Poland
Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
🇵🇱Kraków, Poland
Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
🇵🇱Pinczow, Poland
Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
🇵🇱Sanok, Poland
Departament of Cardiology, University Hospital, Ljubljana
🇸🇮Ljubljana, Slovenia
I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
🇵🇱Warszawa, Poland