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

NCT00564382 | Completed DMC

• 1 other identifier: Emergency001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Infarction; Ischemia; Magnetic Resonance Imaging

Keywords

Acute coronary syndrome; Cardiac Magnetic Resonance Imaging; Contrast agents; Gadolinium

Outcome Measures

Primary Outcomes (1)

• The difference between the Time to diagnosis, measured from the first negative Troponin to the publication of the CMR study report

  prospective

Study Arms (1)

1

OTHER

Patients with ACS in the emergency department and primary tests (ECG, TNT) negative for myocardial ischemia

Procedure: Cardiac magnetic Resonance study

Interventions

Cardiac magnetic Resonance study PROCEDURE

Routine cardiac MR study including contrast application

Also known as: Standard of care

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Calgary: lead

Study Sites (1)

Stephenson CMR Centre at Foothills Medical Centre, University of Calgary

Calgary, Alberta, T2N 2T9, Canada

Location

Related Publications (7)

• 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. doi: 10.1016/s0735-1097(02)02336-7. No abstract available.

  PMID: 12383588 BACKGROUND

• 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. doi: 10.1161/01.cir.0000047527.11221.29.

  PMID: 12566362 BACKGROUND

• 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. doi: 10.1016/j.jacc.2004.08.056.

  PMID: 15582315 BACKGROUND

• 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. doi: 10.1016/j.jacc.2005.11.059. Epub 2006 Mar 20.

  PMID: 16580532 BACKGROUND

• 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. doi: 10.1016/s0735-1097(03)00717-4.

  PMID: 12906982 BACKGROUND

• 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. doi: 10.1161/hc2301.092121.

  PMID: 11401931 BACKGROUND

• 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. doi: 10.1161/01.CIR.0000127428.10985.C6. Epub 2004 May 3.

  PMID: 15123531 BACKGROUND

Related Links

• Libin Institute of Alberta

MeSH Terms

Conditions

Infarction; Ischemia; Acute Coronary Syndrome

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Oliver Strohm, MD, FESC

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adunct Research Associate Professor

Study Record Dates

• First Submitted: November 26, 2007
• First Posted: November 28, 2007
• Study Start: November 1, 2007
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: October 4, 2011

Record last verified: 2011-10

Locations

CA (1)