Myocardial Infarction Clinical Trial
Official 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.
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.
;
Observational Model: Case Control, Time Perspective: Cross-Sectional
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