Clinical trial NCT01642784: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction
Official title: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Registry(CORAMIreg)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocardial Infarction
Keywords: STEMI
NSTEMI
revascularization
stents
Lead sponsor: Fundacja Ośrodek Badań Medycznych
Sponsor class: OTHER
First posted: 2012-07-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Death
timeFrame: At 12 months
measure: Stent thrombosis
timeFrame: At 12 months
measure: reMI (repeat myocardial infarctions)
timeFrame: At 12 months
measure: urgent TVR (target vessel revascularization) at 12 months
timeFrame: 12 months and at 12 months
measure: Planned TVR
timeFrame: At 12 months
Secondary outcomes:
measure: Angiographic complications
timeFrame: During hospitalization
measure: Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft))
timeFrame: During hospitalization and at 12 months
measure: Complete contrast dose in ml
timeFrame: During hospitalization and at 12 months
measure: Complete radiation dose in mGy
timeFrame: During hospitalization and at 12 months
Other outcomes:
Locations:
city: Kraków
country: Poland
facility: Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
city: Ostrowiec Swietokrzyski
country: Poland
facility: Centrum Kardiologii Inwazyjnej GVM Carint
city: Oświecim
country: Poland
facility: Centrum Kardiologii Inwazyjnej GVM Carint
city: Pinczow
country: Poland
facility: Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
city: Sanok
country: Poland
facility: Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
city: Tarnów
country: Poland
facility: Pracownia Hemodynamiki Szpital im. E. Szczeklika
city: Warszawa
country: Poland
facility: I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
city: Ljubljana
country: Slovenia
facility: Departament of Cardiology, University Hospital, Ljubljana
Study officials:
affiliation: Pracownia Hemodynamiki Szpital im. E. Szczeklika
name: Bogdan Januś, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: