Myocardial Infarction
Conditions
Keywords
STEMI, NSTEMI, revascularization, stents
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.
Interventions
DEVICEPrimary PCI of culprit lesion in IRA with drug eluting stent (DES)
Primary PCI of culprit lesion in IRA with drug eluting stent (DES)
DEVICEPrimary 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
Sponsors
Fundacja Ośrodek Badań Medycznych
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Planned TVR | At 12 months | Rates of planned TVR (PCI + CABG) at 12 months |
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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) |
Countries
Poland, Slovenia
Outcome results
None listed