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

NCT00869245 | Completed

• 2 other identifiers: IRB00008247AHA Identification # 0980008N
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Chest Pain

Keywords

ACS; Acute Coronary Syndrome; Chest pain; Cardiac MRI; CMR; Risk Stratification; Emergency Department

Outcome Measures

Primary Outcomes (1)

• Therapeutic efficacy: Length of stay

  Duration of Initial Hospitalization

Secondary Outcomes (4)

• Therapeutic efficacy: Correct cardiovascular admission decision

  Duration of Initial Hospitalization

• Therapeutic efficacy: Non-therapeutic cardiac catheterizations

  30 days

• Diagnostic thinking efficacy: change in diagnostic certainty

  30 days

• Cost of index hospitalization

  Duration of Initial Hospitalization

Study Arms (2)

1

EXPERIMENTAL

Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.

Other: OU - Cardiac MRI

2

EXPERIMENTAL

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

Interventions

OU - Cardiac MRI OTHER

During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.

1

OU - Conventional Care Testing OTHER

Patients in the conventional testing arm will undergo testing as determined by their treating physician.

2

Eligibility Criteria

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

You may qualify if:

• 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\*\*

You may not qualify if:

• 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)

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• American Heart Association: collaborator

Study Sites (1)

Wake Forest University Baptist Medical Center - Emergency Department

Winston-Salem, North Carolina, 27157, United States

Location

Related Publications (40)

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MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain; Emergencies

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Chadwick Miller, M.D.

  WFUBMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2009
• First Posted: March 25, 2009
• Study Start: March 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2011
• Last Updated: November 8, 2017

Record last verified: 2017-04

Locations

US (1)