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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oliver Strohm, University of Calgary
ClinicalTrials.gov Identifier:
NCT00564382
First received: November 26, 2007
Last updated: October 2, 2011
Last verified: October 2011
  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

Resource links provided by NLM:


Further study details as provided by 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 ] [ 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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:

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:
Infarction
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on September 16, 2014