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Sponsored by: |
University of Calgary |
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Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00564382 |
In this study, we investigate the role of Cardiac Magnetic Resonance Imaging in patients with suspected, but not yet proven "acute cardiac syndrome ACS". Patients are included, if they presented to the local Emergency Department with chest pain, but the first tests in the Emergency Department are negative or not clearly indicative of cardiac ischemia. For example, the first lab value Troponin T is negative or borderline elevated; or the first ECG is not clearly indicative of ischemia. The standard procedure for these patients is to wait 4-6 hours and then repeat the test; if they continue to be negative, the patients are discharged home, if the have become positive, an invasive coronary artery angiography has to be performed. We think, that a CMR study can shorten the time needed to make the decision of either "discharge" or "admit to CCU and perform a coronary artery angiography". CMR has been shown to be the gold standard for heart function (thus, can see even subtle wall motion abnormalities), for tissue characterization (so-called T2-weighted images can identify tissue edema (swelling); perfusion images can identify areas with reduced blood supply; late enhancement images can safely identify fibrotic or irreversibly damaged tissue) and can even be used to stress the patients to exclude a critical or non-critical narrowing of coronary arteries.
The primary endpoint of this study will be the impact of CMR on the time-to-decision in these patients.
It should be possible to a) identify all patients WITH an acute infarct by CMR and send them to a cath lab sooner compared to waiting for a second test; b) identify all patients WITHOUT an acute infarct and c) perform a stress test in those patients to exclude severe coronary artery disease.
Condition | Intervention |
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Infarction Ischemia Magnetic Resonance Imaging |
Procedure: Cardiac magnetic Resonance study |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Cardiac MRI for the Diagnosis of Unstable Angina/ NSTEMI in the Emergency Room |
Estimated Enrollment: | 100 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | November 2009 |
Estimated Primary Completion Date: | November 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Patients with ACS in the emergency department and primary tests (ECG, TNT) negative for myocardial ischemia
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Procedure: Cardiac magnetic Resonance study
Routine cardiac MR study including contrast application
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Oliver Strohm, MD, FESC | 403 944 8806 | oliver.strohm@ucalgary.ca |
Contact: Matthias Friedrich, MD, FESC | 403 944 8806 | matthias.friedrich@ucalgary.ca |
Canada, Alberta | |
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary | Recruiting |
Calgary, Alberta, Canada, T2N 2T9 | |
Contact: Oliver Strohm, MD, FESC 404 944 8806 oliver.strohm@ucalgary.ca | |
Principal Investigator: Oliver Strohm, MD, FESC | |
Sub-Investigator: Andreas Kumar, MD | |
Sub-Investigator: Sarah G Weeks, MD FRCP | |
Sub-Investigator: Lynne Fisk, RN | |
Sub-Investigator: Sandra Rivest, RN | |
Sub-Investigator: Andrew Howarth, MD | |
Sub-Investigator: Matthias G Friedrich, MD FESC |
Principal Investigator: | Oliver Strohm, MD, FESC | University of Calgary |
Responsible Party: | University of Calgary ( Oliver Strohm, MD, FESC. Associate Professor, Departments. of Cardiac Sciences and Radiology, University of Calgary ) |
Study ID Numbers: | Emergency001 |
Study First Received: | November 26, 2007 |
Last Updated: | May 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00564382 |
Health Authority: | Canada: Health Canada |
Acute coronary syndrome Cardiac Magnetic Resonance Imaging Contrast agents Gadolinium |
Necrosis Acute Coronary Syndrome Angina Pectoris Emergencies |
Ischemia Infarction Angina, Unstable |
Disease Attributes Pathologic Processes |