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Myocardial InfarctionCORAMINCT01218815

Complete Infarct Related Artery Revascularization

A study testing IRA stenting in culprit lesion only and IRA stenting in people with Myocardial Infarction and Coronary Artery Disease, run by Fundacja Ośrodek Badań Medycznych at 10 sites in 2 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

CORAMI trial is a prospective, international, multicenter randomized study which will be performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary intervention) duty and patient enrollment will continue for 18 months (October 2010 - March 2012).The aim of the study is to compare strategy… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IRA stenting in culprit lesion only and IRA stenting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1 participants
Where
10 sitesin 2 countries
Study dates
Oct 2010to Oct 2011
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • diagnosis of STEMI (according to ESC 2007 definition)
  • Chest pain onset <12 hours
  • signed informed consent
  • 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%) with TIMI 3 flow after PCI of the 1st target/culprit lesion
  • Over 18 years of age
  • IRA diameter ≥ 2.5 mm

Who cannot join

  • 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
  • Contraindications to DES stent implantation
  • Lesion diameters unsuitable for intended stent platform
  • Active bleeding or coagulopathy
Show all 10Show fewer
  • Patient in cardiogenic shock (<90mmHg SBP and/or requiring IABP - intraaortic balloon pump - or vasopressors) - Killip 4 class
  • Patient has Left Bundle Branch Block (LBBB) or pacemaker rhythm
  • No future patient cooperation expected
  • Patient is participating in another clinical study

Trial locations and contacts

10 sites in 2 countries.

10 sites in 2 countries

Poland9 sites

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

    Krakow, Kraków, 30-693

  • Department of Interventional Cardiology, Jagiellonian University Medical College

    Krakow

  • Centrum Kardiologii Inwazyjnej GVM Carint

    Ostrowiec Świętokrzyski, Szymanowskiego 11, 27-400

  • Centrum Kardiologii Inwazyjnej GVM Carint

    Oświęcim, Wysokie Brzegi 4, 32-600

  • Podkarpackie Centrum Interwencji Sercowo -Naczyniowych NZOZ

    Sanok, Podkarpackie Voivodeship, 38-500

  • SP ZZOZ Powiatowy Szpital Specjalistyczny

    Stalowa Wola, Stalowa Wola, 37-450

  • Pracownia Hemodynamiki Szpital im. E. Szczeklika

    Tarnów, Szpitalna 13, 33-100

  • I Katedra i Klinika Kardiologii, Warszawski Uniwersytet Medyczny

    Warsaw, Banacha 1a, 02-097

  • Instytut Kardiologii im. Prymasa Tysiąclecia Stefana Kardynała Wyszyńskiego

    Warsaw, Warszawa, 04-628

Other trials in Poland

Slovenia1 site

  • Departament of Cardiology, University Hospital, Ljubljana

    Ljubljana, Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: Complete Infarct Related Artery Revascularization in Acute Myocardial Infarction Patients - CORAMI Trial

CORAMI trial is a prospective, international, multicenter randomized study which will be performed in experienced invasive facility centres with 24/7 PCI (percutaneous coronary intervention) duty and patient enrollment will continue for 18 months (October 2010 - March 2012).The aim of the study is to compare strategy of complete vs target lesion-only primary PCI in IRA (infarct related artery) in STEMI (ST elevation myocardial infarction) patients.

Being tested
IRA stenting in culprit lesion only, IRA stenting
Medical subject headings
Myocardial Infarction, Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IRA stenting in culprit lesion onlyProcedure or surgery

    stenting

  • IRA stentingProcedure or surgery

    Complete IRA revascularization

Study groups in NCT01218815
Study groupRoleWhat they receive
Culprit lesion IRA RevascularizationExperimentalPrimary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
Receives: Procedure: IRA stenting in culprit lesion only
Complete IRA revascularizationActive comparatorPrimary PCI of culprit lesion in IRA with DES stent
Receives: Procedure: IRA stenting

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade)

    This is a combined end-point of ST - segment resolution >70% assessed directly after PCI

    + MBG 3 assessed directly after PCI (assessments by ECG and QCA Corelab).

    Measured: in-hospital directly after PCI

Secondary outcomes (2)

  1. Clinical major ischemic events

    1. Death at 12-month clinical follow-up
    2. Stent thrombosis at 12-month follow-up according to ARC definition
    3. reMI at 12 months
    4. urgent TVR at 12 months

    Measured: 12-months

  2. Adverse events and complications during hospital stay

    1. 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. urgent in-hospital Target Vessel Revascularization (PCI and/or CABG - coronary artery bypass graft)

    Measured: during patient index hospitalization (up to 7 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2010 (estimated)
  2. Study startOct 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

Why it stopped: Due to very low enrollment rate the study was terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218815
Sponsor's protocol ID
3.0/2010
Acronym
CORAMI
Status last verified
Mar 2015
First submitted
1 Oct 2010
Last updated
6 Mar 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing IRA stenting in culprit lesion only and IRA stenting in people with Myocardial Infarction and Coronary Artery Disease, run by Fundacja Ośrodek Badań Medycznych at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Poland, Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to very low enrollment rate the study was terminated.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ST resolution in ECG (electrocardiogram) and MBG (myocardial blush grade) (time frame: in-hospital directly after PCI). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01218815.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2015.

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