CMR in the Assessment of Patient With ACS in the Emergency Room
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Purpose
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 |
|---|---|
|
Infarction Ischemia Magnetic Resonance Imaging |
Procedure: Cardiac magnetic Resonance study |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Cardiac MRI for the Diagnosis of Unstable Angina/ NSTEMI in the Emergency Room |
- The difference between the Time to diagnosis, measured from the first negative Troponin to the publication of the CMR study report [ Time Frame: prospective ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | November 2007 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
Patients with ACS in the emergency department and primary tests (ECG, TNT) negative for myocardial ischemia
|
Procedure: Cardiac magnetic Resonance study
Routine cardiac MR study including contrast application
Other Name: Standard of care
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18+ years of age, informed consent obtained
- Chest pain, suggestive of coronary artery disease, plus at least one more point from the TIMI risk score (TIMI score ≥2)
- Troponin is negative on 1st draw; based on the Emergency Room Physician's discretion, a 2nd Troponin draw is indicated and pending
Exclusion Criteria:
- ST elevation on ECG, new Q-waves or dynamic ST-segment changes, 2nd or 3rd degree AV-block
- Unstable patients
- PCI or myocardial infarction within 3 months
- Ferromagnetic objects precluding MRI imaging (e.g., pacemaker, defibrillator, cerebral aneurysm clip, metal in eye, insulin pumps, neural stimulators, cochlea implants)
- Pregnancy
- Extreme claustrophobia
- Asthma
- Inability to lie flat
Contacts and Locations| Canada, Alberta | |
| Stephenson CMR Centre at Foothills Medical Centre, University of Calgary | |
| Calgary, Alberta, Canada, T2N 2T9 | |
| Principal Investigator: | Oliver Strohm, MD, FESC | University of Calgary |
More Information
Additional Information:
Publications:
| Responsible Party: | Oliver Strohm, adunct Research Associate Professor, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00564382 History of Changes |
| Other Study ID Numbers: | Emergency001 |
| Study First Received: | November 26, 2007 |
| Last Updated: | October 2, 2011 |
| Health Authority: | Canada: Health Canada |
Keywords provided by University of Calgary:
|
Acute coronary syndrome Cardiac Magnetic Resonance Imaging Contrast agents Gadolinium |
Additional relevant MeSH terms:
|
Emergencies Infarction Ischemia |
Disease Attributes Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 23, 2013