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Due to very low enrollment rate the study was terminated.
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CORAMI trial is a prospective, international, multicenter randomized study which will be performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary intervention) duty and patient enrollment will continue for 18 months (October 2010 - March 2012).The aim of the study is to compare strategy of complete vs target lesion-only primary PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Culprit lesion IRA Revascularization | Experimental | 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 | Active Comparator | Primary PCI of culprit lesion in IRA with DES stent |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IRA stenting in culprit lesion only | Procedure | stenting |
| |
| Measure | Description | Time Frame |
|---|---|---|
| ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade) | This is a combined end-point of ST - segment resolution >70% assessed directly after PCI + MBG 3 assessed directly after PCI (assessments by ECG and QCA Corelab). | in-hospital directly after PCI |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical major ischemic events |
| 12-months |
| Adverse events and complications during hospital stay |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dariusz Dudek, MD, PhD | Department of Interventional Cardiology, Jagiellonian University Medical College in Krakow, Poland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny | Warsaw | Banacha 1a | 02-097 | Poland | ||
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| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D003324 | Coronary Artery Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| IRA stenting |
| Procedure |
Complete IRA revascularization |
|
|
| during patient index hospitalization (up to 7 days) |
| Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o. |
| Krakow |
| Kraków |
| 30-693 |
| Poland |
| Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ | Sanok | Podkarpackie Voivodeship | 38-500 | Poland |
| SP ZZOZ Powiatowy Szpital Specjalistyczny | Stalowa Wola | Stalowa Wola | 37-450 | Poland |
| Pracownia Hemodynamiki Szpital im. E. Szczeklika | Tarnów | Szpitalna 13 | 33-100 | Poland |
| Centrum Kardiologii Inwazyjnej GVM Carint | Ostrowiec Świętokrzyski | Szymanowskiego 11 | 27-400 | Poland |
| Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego | Warsaw | Warszawa | 04-628 | Poland |
| Centrum Kardiologii Inwazyjnej GVM Carint | Oświęcim | Wysokie Brzegi 4 | 32-600 | Poland |
| Department of Interventional Cardiology, Jagiellonian University Medical College | Krakow | Poland |
| Departament of Cardiology, University Hospital, Ljubljana | Ljubljana | Ljubljana | 1000 | Slovenia |
| D007238 |
| Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D003327 | Coronary Disease |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |