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Cardiovascular DiseasesCOATNCT00968383

Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment

A study testing Beta adrenergic blockers, Platelet inhibitors and Statins in people with Cardiovascular Diseases and Heart Diseases, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.

Terminated

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

Official record
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Trial summary

The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients with preserved infarct zone viability improves left ventricular systolic function and volumes at 6 months follow-up. Read more about this study

Who is it for?
Ages 18 to 85 years
What is being tested?
Beta adrenergic blockers, Platelet inhibitors and Statins
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 sitePoland
Study dates
Sep 2009to Dec 2012
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Enrollment 3-28 days after an acute myocardial infarction.
  • Infarct related artery occlusion (TIMI 0 or 1).
  • High risk: left ventricular ejection fraction (LVEF)<50% or LVEF>50% and proximal coronary occlusion.
  • Preserved infarct zone viability (necrosis transmurality <50% in at least 4 segments out of 17 according to AHA classification).

Who cannot join

  • Unstable clinical condition

Trial locations and contacts

1 site in 1 country.

Poland1 site

  • Institute of Cardiology

    Warsaw, 04-628

Other trials in Poland

About this study

Official title: Late Percutaneous Coronary Intervention of the Occluded Infarct-Related Artery in Patients With Preserved Infarct Zone Viability Determined With Magnetic Resonance Imaging

The purpose of this study is to determine whether opening an occluded infarcted artery 3-28 days after an acute myocardial infarction in high-risk asymptomatic patients with preserved infarct zone viability improves left ventricular systolic function and volumes at 6 months follow-up. The secondary purpose is to assess the changes in myocardial tissue characteristics after late percutaneous coronary intervention (PCI).

Read the detailed description

Rapid restoration of blood flow in the infarct-related artery (IRA), one of the cornerstones of contemporary treatment of acute myocardial infarction (MI) prevents myocardial necrosis and its consequences. However, due to late presentation or failed fibrinolytic therapy up to one third of patients have persistently occluded IRA after MI.

Recently, the Occluded Artery Trial (OAT) has demonstrated that percutaneous coronary intervention (PCI) with optimal medical therapy does not reduce the frequency of major adverse events compared to optimal medical therapy alone when performed on days 3-28 post MI in stable patients. Assessment of infarct zone viability was not used as an inclusion/exclusion criterion in the main OAT trial.

Several studies confirm that patients with left ventricular systolic dysfunction and preserved myocardial viability (necrosis transmurality<50% in most segments of the infarct zone) assessed with magnetic resonance imaging benefit from revascularization.

Late opening of the occluded infarct-related artery only in patients with preserved myocardial tissue viability may lead to improvement of left ventricular volumes and function.

Being tested
Beta adrenergic blockers, Platelet inhibitors, Statins, ACE inhibitors and/or ARB and/or AA, PCI with stenting
Keywords
Acute Coronary Syndrome, Myocardial infarction, Infarct Related Artery, Percutaneous Coronary Intervention, Medical treatment, Tissue Viability, Magnetic Resonance
Medical subject headings
Cardiovascular Diseases, Heart Diseases, Myocardial Infarction, Heart Failure, Acute Coronary Syndrome

What participants receive

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

  • Beta adrenergic blockersDrug

    Participants will receive beta adrenergic blockers.

  • Platelet inhibitorsDrug

    Participants will receive platelet inhibitors.

  • StatinsDrug

    Participants will receive statins.

  • ACE inhibitors and/or ARB and/or AADrug

    Participants will receive ACE inhibitors and/or ARB and/or AA

  • PCI with stentingProcedure or surgery

    Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting.

Study groups in NCT00968383
Study groupRoleWhat they receive
Optimal medical therapyActive comparatorConventional medical management, including aspirin, clopidogrel, statins, beta blockers, angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB) and/or aldosterone antagonist and risk factor modification
Receives: Drug: Beta adrenergic blockers; Drug: Platelet inhibitors; Drug: Statins; Drug: ACE inhibitors and/or ARB and/or AA
PCI with optimal medical therapyExperimentalConventional medical management, including aspirin, clopidogrel, statins, beta blockers, angiotensin converting enzyme (ACE) inhibitors and/or angiotensin receptor blocker (ARB) and/or aldosterone antagonist and risk factor modification plus percutaneous coronary intervention and coronary stenting
Receives: Drug: Beta adrenergic blockers; Drug: Platelet inhibitors; Drug: Statins; Drug: ACE inhibitors and/or ARB and/or AA; Procedure: PCI with stenting

What is being measured

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

  1. change in systolic wall thickening (SWT)

    Measured: 6 months

Secondary outcomes (5)

  1. change in left ventricular ejection fraction (LVEF)

    Measured: 6 months

  2. change in wall motion score index (WMSI)

    Measured: 6 months

  3. change in left ventricular end-diastolic volume (LVEDV)

    Measured: 6 months

  4. change in left ventricular end-systolic volume (LVESV)

    Measured: 6 months

  5. myocardial tissue characteristics

    Measured: 3-5 days

Timeline

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

  1. First posted31 Aug 2009 (estimated)
  2. Study startSep 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Why it stopped: The study was prematurely terminated due to low enrollment.

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
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00968383
Sponsor's protocol ID
2.50/V/09
Acronym
COAT
Status last verified
May 2015
First submitted
30 Jun 2009
Last updated
14 May 2015
Results posted
No
Data monitoring committee
No

Publications

  • Hochman JS, Lamas GA, Knatterud GL, Buller CE, Dzavik V, Mark DB, Reynolds HR, White HD; Occluded Artery Trial Research Group. Design and methodology of the Occluded Artery Trial (OAT). Am Heart J. 2005 Oct;150(4):627-42. doi: 10.1016/j.ahj.2005.07.002.

    PubMed 16209957

  • Hochman JS, Lamas GA, Buller CE, Dzavik V, Reynolds HR, Abramsky SJ, Forman S, Ruzyllo W, Maggioni AP, White H, Sadowski Z, Carvalho AC, Rankin JM, Renkin JP, Steg PG, Mascette AM, Sopko G, Pfisterer ME, Leor J, Fridrich V, Mark DB, Knatterud GL; Occluded Artery Trial Investigators. Coronary intervention for persistent occlusion after myocardial infarction. N Engl J Med. 2006 Dec 7;355(23):2395-407. doi: 10.1056/NEJMoa066139. Epub 2006 Nov 14.

    PubMed 17105759

  • Malek LA, Reynolds HR, Forman SA, Vozzi C, Mancini GB, French JK, Dziarmaga M, Renkin JP, Kochman J, Lamas GA, Hochman JS. Late coronary intervention for totally occluded left anterior descending coronary arteries in stable patients after myocardial infarction: Results from the Occluded Artery Trial (OAT). Am Heart J. 2009 Apr;157(4):724-32. doi: 10.1016/j.ahj.2008.12.008.

    PubMed 19332202

  • Kim RJ, Wu E, Rafael A, Chen EL, Parker MA, Simonetti O, Klocke FJ, Bonow RO, Judd RM. The use of contrast-enhanced magnetic resonance imaging to identify reversible myocardial dysfunction. N Engl J Med. 2000 Nov 16;343(20):1445-53. doi: 10.1056/NEJM200011163432003.

    PubMed 11078769

  • Malek LA, Silva JC, Bellenger NG, Nicolau JC, Klopotowski M, Spiewak M, Rassi CH, Lewandowski Z, Kruk M, Rochitte CE, Ruzyllo W, Witkowski A. Late percutaneous coronary intervention for an occluded infarct-related artery in patients with preserved infarct zone viability: a pooled analysis of cardiovascular magnetic resonance studies. Cardiol J. 2013;20(5):552-9. doi: 10.5603/CJ.2013.0141.

    PubMed 24297771

Questions about this trial

What is this clinical trial studying?

A study testing Beta adrenergic blockers, Platelet inhibitors and Statins in people with Cardiovascular Diseases and Heart Diseases, run by National Institute of Cardiology, Warsaw, Poland at 1 site in Poland.

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 4 inclusion and 1 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 14 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. 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: The study was prematurely terminated due to low enrollment.). 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?

change in systolic wall thickening (SWT) (time frame: 6 months). 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 NCT00968383, which also lists 5 linked publications.

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 14 May 2015.

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