Primary PCI of culprit lesion in IRA with drug eluting stent (DES)
DevicePrimary PCI of culprit lesion in IRA with drug eluting stent (DES)
NCT Number: NCT01642784
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.
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Notify Me18 year and older
All sexes
Observational
Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o., Krakow, Poland
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Primary PCI of culprit lesion in IRA with drug eluting stent (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
Time frame: At 12 months
Death rates at 12-month clinical follow-up
Time frame: At 12 months
Rates of stent thrombosis at 12-month follow-up according to ARC definition
Time frame: At 12 months
Rates of reMI at 12 months
Time frame: 12 months and at 12 months
Rates of urgent TVR at 12 months
Time frame: At 12 months
Rates of planned TVR (PCI + CABG) at 12 months
Time frame: 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)
Time frame: During hospitalization and at 12 months
Urgent in-hospital Target Vessel Revascularization (PCI and/or CABG)
Time frame: During hospitalization and at 12 months
Complete contrast dose in ml
Time frame: During hospitalization and at 12 months
Complete radiation dose in mGy
Fundacja Ośrodek Badań Medycznych
Other
Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Registry(CORAMIreg)
Acronym: CORAMIreg
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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