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Completed

NCT Number: NCT01642784

Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o., Krakow, Poland

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About this study

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:

  • 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).
  • comparing chosen treatment strategies for multiple lesion IRA
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)):
  • Target/culprit lesion which requires immediate stenting (>50 - 100%) and
  • 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

Treatment and study plan

Primary PCI of culprit lesion in IRA with drug eluting stent (DES)

Device

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

Device

Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES

Primary outcomes

  1. Death

    Time frame: At 12 months

    Death rates at 12-month clinical follow-up

  2. Stent thrombosis

    Time frame: At 12 months

    Rates of stent thrombosis at 12-month follow-up according to ARC definition

  3. reMI (repeat myocardial infarctions)

    Time frame: At 12 months

    Rates of reMI at 12 months

  4. urgent TVR (target vessel revascularization) at 12 months

    Time frame: 12 months and at 12 months

    Rates of urgent TVR at 12 months

  5. Planned TVR

    Time frame: At 12 months

    Rates of planned TVR (PCI + CABG) at 12 months

Secondary outcomes

  1. Angiographic complications

    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)

  2. Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft))

    Time frame: During hospitalization and at 12 months

    Urgent in-hospital Target Vessel Revascularization (PCI and/or CABG)

  3. Complete contrast dose in ml

    Time frame: During hospitalization and at 12 months

    Complete contrast dose in ml

  4. Complete radiation dose in mGy

    Time frame: During hospitalization and at 12 months

    Complete radiation dose in mGy

Sponsors and collaborators

Lead sponsor

Fundacja Ośrodek Badań Medycznych

Other

Registry information

Official study title

Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Registry(CORAMIreg)

Acronym: CORAMIreg

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jul 17, 2012
Registry last updated
Jul 3, 2013

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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