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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culprit lesion IRA revascularization | Culprit lesion IRA revascularization |
| |
| Complete IRA revascularization | Complete IRA revascularization |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
|
| 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 |
| 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)) |
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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)):
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bogdan Januś, MD, PhD | Pracownia Hemodynamiki Szpital im. E. Szczeklika | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o. | Krakow | 30-693 | Poland | |||
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| Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another 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 |
|
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 |
| Centrum Kardiologii Inwazyjnej GVM Carint |
| Ostrowiec Świętokrzyski |
| 27-400 |
| Poland |
| Centrum Kardiologii Inwazyjnej GVM Carint | Oświecim | 32-600 | Poland |
| Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie | Pińczów | Poland |
| Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ | Sanok | 38-500 | Poland |
| Pracownia Hemodynamiki Szpital im. E. Szczeklika | Tarnów | 33-100 | Poland |
| I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny | Warsaw | 02-097 | Poland |
| Departament of Cardiology, University Hospital, Ljubljana | Ljubljana | Slovenia |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D000072658 | Non-ST Elevated Myocardial Infarction |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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| ID | Term |
|---|---|
| D054855 | Drug-Eluting Stents |
| ID | Term |
|---|---|
| D015607 | Stents |
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
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