Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT00869245
First received: March 24, 2009
Last updated: February 15, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares types of cardiac tests performed while receiving treatment in an observation unit. Patients will either undergo cardiac MRI testing or conventional care testing. Patients treated in the conventional care testing group will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.


Condition Intervention
Acute Coronary Syndrome
Chest Pain
Other: OU - Cardiac MRI
Other: OU - Conventional Care Testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain

Resource links provided by NLM:


Further study details as provided by Wake Forest Baptist Health:

Primary Outcome Measures:
  • Therapeutic efficacy: Length of stay [ Time Frame: Duration of Initial Hospitalization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Therapeutic efficacy: Correct cardiovascular admission decision [ Time Frame: Duration of Initial Hospitalization ] [ Designated as safety issue: No ]
  • Therapeutic efficacy: Non-therapeutic cardiac catheterizations [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Diagnostic thinking efficacy: change in diagnostic certainty [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Cost of index hospitalization [ Time Frame: Duration of Initial Hospitalization ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: March 2009
Study Completion Date: October 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
Other: OU - Cardiac MRI
During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.
Experimental: 2
Conventional care cardiac testing. Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.
Other: OU - Conventional Care Testing
Patients in the conventional testing arm will undergo testing as determined by their treating physician.

Detailed Description:

Despite spending $12 billion annually on the emergency evaluation of chest pain in the US, only 15% of admitted patients have a cardiac cause of their presenting symptoms. Observation units (OU) improve resource utilization, are endorsed by the ACC/AHA guidelines, but have seen limited implementation in non-low risk chest pain patients due to limitations of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The superior accuracy of CMR could decrease testing resulting from false positive results. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers.

Research hypotheses:

OU-CMR will have superior therapeutic efficacy to OU-conventional testing.

An OU-CMR strategy will have higher diagnostic thinking efficacy than OU-conventional testing.

Methods summary:

To address the question of feasibility of a CMR approach to managing patients at intermediate risk for ACS, we propose a randomized clinical trial of 120 patients at intermediate risk of ACS that present to the ED of Wake Forest University Baptist Medical Center (WFUBMC) for evaluation of chest pain. All patients will receive care in an OU, and will be randomized to CMR, or conventional testing. CMR participants will undergo cardiac markers and CMR testing; conventional testing participants will undergo serial cardiac markers followed by conventional cardiac testing. ACS (infarction, death, coronary revascularization, unstable angina) will be assessed by evaluation of hospital course and phone follow-up at 30 days. Cost of hospital care will be compared among groups.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18 years
  • Chest discomfort or other symptoms consistent with possible ACS
  • TIMI risk score ≥ 1 or physician impression* of intermediate or high likelihood symptoms represent ACS
  • Patient requires an inpatient or observation unit evaluation for their chest pain
  • The treating physician feels the patient could be discharged home if cardiac disease was excluded
  • ED attending feels patient is safe for observation unit care**

Exclusion Criteria:

  • Initial troponin I > 1.0 ng/ml
  • New ST-segment elevation (≥1mV) or depression (≥2 mV)
  • Contra-indications to MRI (listed below)
  • Unable to lie flat
  • Hypotension (systolic < 90 mm Hg)
  • Renal insufficiency (estimated GFR < 45 cc/min) or end stage renal disease
  • Life expectancy less than 3 months
  • Patient refusal of medical record review and follow-up at 30 days
  • Pregnancy
  • Liver, heart, or kidney transplant
  • Chronic liver disease
  • Unable to speak English or Spanish
  • The ED attending feels that cardiac catheterization is indicated
  • The ED care provider intends to order a CT coronary angiogram

(*)Physicians are encouraged to use the 2007 ACC/AHA guidelines for the management of patients with NSTE ACS as a framework for this assessment.(1)

(**)These patients should generally not be considered for observation unit care: PCI / CAGB in past 6 months, multiple stents, multiple prior MIs

Contraindications to MRI: (Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia)

  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: NCT00869245

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center - Emergency Department
Winston-Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Wake Forest Baptist Health
American Heart Association
Investigators
Principal Investigator: Chadwick Miller, M.D. WFUBMC
  More Information

Additional Information:
Publications:
Anderson JL, Adams CD, Antman EM, Bridges CR, Califf RM, Casey DE Jr, Chavey WE 2nd, Fesmire FM, Hochman JS, Levin TN, Lincoff AM, Peterson ED, Theroux P, Wenger NK, Wright RS, Smith SC Jr, Jacobs AK, Halperin JL, Hunt SA, Krumholz HM, Kushner FG, Lytle BW, Nishimura R, Ornato JP, Page RL, Riegel B; American College of Cardiology; American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction); American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions; Society of Thoracic Surgeons; American Association of Cardiovascular and Pulmonary Rehabilitation; Society for Academic Emergency Medicine. ACC/AHA 2007 guidelines for the management of patients with unstable angina/non ST-elevation myocardial infarction: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Writing Committee to Revise the 2002 Guidelines for the Management of Patients With Unstable Angina/Non ST-Elevation Myocardial Infarction): developed in collaboration with the American College of Emergency Physicians, the Society for Cardiovascular Angiography and Interventions, and the Society of Thoracic Surgeons: endorsed by the American Association of Cardiovascular and Pulmonary Rehabilitation and the Society for Academic Emergency Medicine. Circulation. 2007 Aug 14;116(7):e148-304. Epub 2007 Aug 6. No abstract available. Erratum in: Circulation. 2008 Mar 4;117(9):e180.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Chadwick Miller, MD, Wake Forest University Baptist Medical Center
ClinicalTrials.gov Identifier: NCT00869245     History of Changes
Other Study ID Numbers: IRB00008247, AHA Identification # 0980008N
Study First Received: March 24, 2009
Last Updated: February 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Wake Forest Baptist Health:
ACS
Acute Coronary Syndrome
Chest pain
Cardiac MRI
CMR
Risk Stratification
Emergency Department

Additional relevant MeSH terms:
Chest Pain
Acute Coronary Syndrome
Pain
Signs and Symptoms
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
Vascular Diseases

ClinicalTrials.gov processed this record on July 24, 2014