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CMR in the Assessment of Patient With ACS in the Emergency Room

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00564382
First Posted: November 28, 2007
Last Update Posted: October 4, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oliver Strohm, University of Calgary
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac MRI for the Diagnosis of Unstable Angina/ NSTEMI in the Emergency Room

Resource links provided by NLM:


Further study details as provided by Oliver Strohm, University of Calgary:

Primary Outcome Measures:
  • The difference between the Time to diagnosis, measured from the first negative Troponin to the publication of the CMR study report [ Time Frame: prospective ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18+ years of age, informed consent obtained
  2. Chest pain, suggestive of coronary artery disease, plus at least one more point from the TIMI risk score (TIMI score ≥2)
  3. Troponin is negative on 1st draw; based on the Emergency Room Physician's discretion, a 2nd Troponin draw is indicated and pending

Exclusion Criteria:

  1. ST elevation on ECG, new Q-waves or dynamic ST-segment changes, 2nd or 3rd degree AV-block
  2. Unstable patients
  3. PCI or myocardial infarction within 3 months
  4. Ferromagnetic objects precluding MRI imaging (e.g., pacemaker, defibrillator, cerebral aneurysm clip, metal in eye, insulin pumps, neural stimulators, cochlea implants)
  5. Pregnancy
  6. Extreme claustrophobia
  7. Asthma
  8. Inability to lie flat
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00564382


Locations
Canada, Alberta
Stephenson CMR Centre at Foothills Medical Centre, University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
Principal Investigator: Oliver Strohm, MD, FESC University of Calgary
  More Information

Additional Information:
Publications:
Braunwald E, Antman EM, Beasley JW, Califf RM, Cheitlin MD, Hochman JS, Jones RH, Kereiakes D, Kupersmith J, Levin TN, Pepine CJ, Schaeffer JW, Smith EE 3rd, Steward DE, Theroux P, Gibbons RJ, Alpert JS, Faxon DP, Fuster V, Gregoratos G, Hiratzka LF, Jacobs AK, Smith SC Jr; American College of Cardiology; American Heart Association. Committee on the Management of Patients With Unstable Angina. ACC/AHA 2002 guideline update for the management of patients with unstable angina and non-ST-segment elevation myocardial infarction--summary article: a report of the American College of Cardiology/American Heart Association task force on practice guidelines (Committee on the Management of Patients With Unstable Angina). J Am Coll Cardiol. 2002 Oct 2;40(7):1366-74.
Kwong RY, Schussheim AE, Rekhraj S, Aletras AH, Geller N, Davis J, Christian TF, Balaban RS, Arai AE. Detecting acute coronary syndrome in the emergency department with cardiac magnetic resonance imaging. Circulation. 2003 Feb 4;107(4):531-7.
Plein S, Greenwood JP, Ridgway JP, Cranny G, Ball SG, Sivananthan MU. Assessment of non-ST-segment elevation acute coronary syndromes with cardiac magnetic resonance imaging. J Am Coll Cardiol. 2004 Dec 7;44(11):2173-81.
Ingkanisorn WP, Kwong RY, Bohme NS, Geller NL, Rhoads KL, Dyke CK, Paterson DI, Syed MA, Aletras AH, Arai AE. Prognosis of negative adenosine stress magnetic resonance in patients presenting to an emergency department with chest pain. J Am Coll Cardiol. 2006 Apr 4;47(7):1427-32. Epub 2006 Mar 20.
Schulz-Menger J, Gross M, Messroghli D, Uhlich F, Dietz R, Friedrich MG. Cardiovascular magnetic resonance of acute myocardial infarction at a very early stage. J Am Coll Cardiol. 2003 Aug 6;42(3):513-8.
Ricciardi MJ, Wu E, Davidson CJ, Choi KM, Klocke FJ, Bonow RO, Judd RM, Kim RJ. Visualization of discrete microinfarction after percutaneous coronary intervention associated with mild creatine kinase-MB elevation. Circulation. 2001 Jun 12;103(23):2780-3.
Abdel-Aty H, Zagrosek A, Schulz-Menger J, Taylor AJ, Messroghli D, Kumar A, Gross M, Dietz R, Friedrich MG. Delayed enhancement and T2-weighted cardiovascular magnetic resonance imaging differentiate acute from chronic myocardial infarction. Circulation. 2004 May 25;109(20):2411-6. Epub 2004 May 3.

Responsible Party: Oliver Strohm, adunct Research Associate Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT00564382     History of Changes
Other Study ID Numbers: Emergency001
First Submitted: November 26, 2007
First Posted: November 28, 2007
Last Update Posted: October 4, 2011
Last Verified: October 2011

Keywords provided by Oliver Strohm, University of Calgary:
Acute coronary syndrome
Cardiac Magnetic Resonance Imaging
Contrast agents
Gadolinium

Additional relevant MeSH terms:
Infarction
Emergencies
Ischemia
Pathologic Processes
Necrosis
Disease Attributes


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