Trials / Terminated
TerminatedNCT00968383
Cardiovascular Magnetic Resonance for the Occluded Infarct-Related Artery Treatment
Late Percutaneous Coronary Intervention of the Occluded Infarct-Related Artery in Patients With Preserved Infarct Zone Viability Determined With Magnetic Resonance Imaging
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 11 (actual)
- Sponsor
- National Institute of Cardiology, Warsaw, Poland · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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. The secondary purpose is to assess the changes in myocardial tissue characteristics after late percutaneous coronary intervention (PCI).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Beta adrenergic blockers | Participants will receive beta adrenergic blockers. |
| DRUG | Platelet inhibitors | Participants will receive platelet inhibitors. |
| DRUG | Statins | Participants will receive statins. |
| DRUG | ACE inhibitors and/or ARB and/or AA | Participants will receive ACE inhibitors and/or ARB and/or AA |
| PROCEDURE | PCI with stenting | Participants will undergo percutaneous coronary intervention (PCI) and coronary stenting. |
Timeline
- Start date
- 2009-09-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2009-08-31
- Last updated
- 2015-05-14
Locations
1 site across 1 country: Poland
Source: ClinicalTrials.gov record NCT00968383. Inclusion in this directory is not an endorsement.