Myocardial Infarction Clinical Trial
— CORAMIregOfficial title:
Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Registry(CORAMIreg)
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.
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
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 |
Lead Sponsor | Collaborator |
---|---|
Fundacja Osrodek Badan Medycznych |
Poland, Slovenia,
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 |
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