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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Fundacja Ośrodek Badań Medycznych
ClinicalTrials.gov Identifier:
NCT01642784
First received: June 25, 2012
Last updated: July 2, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Myocardial Infarction
Device: 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) and PCI of the other critical lesion in IRA with another DES

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Registry(CORAMIreg)

Resource links provided by NLM:


Further study details as provided by Fundacja Ośrodek Badań Medycznych:

Primary Outcome Measures:
  • Death [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
    Death rates at 12-month clinical follow-up

  • Stent thrombosis [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
    Rates of stent thrombosis at 12-month follow-up according to ARC definition

  • reMI (repeat myocardial infarctions) [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
    Rates of reMI at 12 months

  • urgent TVR (target vessel revascularization) at 12 months [ Time Frame: 12 months and at 12 months ] [ Designated as safety issue: Yes ]
    Rates of urgent TVR at 12 months

  • Planned TVR [ Time Frame: At 12 months ] [ Designated as safety issue: Yes ]
    Rates of planned TVR (PCI + CABG) at 12 months


Secondary Outcome Measures:
  • Angiographic complications [ Time Frame: During hospitalization ] [ Designated as safety issue: Yes ]
    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)

  • Target Vessel Revascularization (PCI and/or CABG (coronary artery bypass graft)) [ Time Frame: During hospitalization and at 12 months ] [ Designated as safety issue: Yes ]
    Urgent in-hospital Target Vessel Revascularization (PCI and/or CABG)

  • Complete contrast dose in ml [ Time Frame: During hospitalization and at 12 months ] [ Designated as safety issue: No ]
    Complete contrast dose in ml

  • Complete radiation dose in mGy [ Time Frame: During hospitalization and at 12 months ] [ Designated as safety issue: No ]
    Complete radiation dose in mGy


Enrollment: 100
Study Start Date: November 2011
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Culprit lesion IRA revascularization
Culprit lesion IRA revascularization
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)
Complete IRA revascularization
Complete IRA revascularization
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 PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01642784

Locations
Poland
Krakowskie centrum Kardiologii Inwazyjnej, Elektroterapii i Angiologii, Carint Scanmed Sp. z o.o.
Kraków, Poland, 30-693
Centrum Kardiologii Inwazyjnej GVM Carint
Ostrowiec Swietokrzyski, Poland, 27-400
Centrum Kardiologii Inwazyjnej GVM Carint
Oświecim, Poland, 32-600
Oddział Kardiologii Inwazyjnej, Elektroterapii i Angiologii w Pińczowie
Pinczow, Poland
Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ
Sanok, Poland, 38-500
Pracownia Hemodynamiki Szpital im. E. Szczeklika
Tarnów, Poland, 33-100
I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny
Warszawa, Poland, 02-097
Slovenia
Departament of Cardiology, University Hospital, Ljubljana
Ljubljana, Slovenia
Sponsors and Collaborators
Fundacja Ośrodek Badań Medycznych
Investigators
Principal Investigator: Bogdan Januś, MD, PhD Pracownia Hemodynamiki Szpital im. E. Szczeklika
  More Information

No publications provided

Responsible Party: Fundacja Ośrodek Badań Medycznych
ClinicalTrials.gov Identifier: NCT01642784     History of Changes
Other Study ID Numbers: 2.0, 2011-11-24
Study First Received: June 25, 2012
Last Updated: July 2, 2013
Health Authority: Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee

Keywords provided by Fundacja Ośrodek Badań Medycznych:
STEMI
NSTEMI
revascularization
stents

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014