Randomized Investigation of Chest Pain Diagnostic Strategies

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Wake Forest Baptist Health
ClinicalTrials.gov Identifier:
NCT01035047
First received: December 17, 2009
Last updated: October 31, 2012
Last verified: October 2012

December 17, 2009
October 31, 2012
January 2010
October 2011   (final data collection date for primary outcome measure)
The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035047 on ClinicalTrials.gov Archive Site
  • Length of Stay [ Time Frame: Duration of Index Hospitalization, an average of 1-2 days ] [ Designated as safety issue: No ]
  • Acute Coronary Syndrome [ Time Frame: Index Hospitalization discharge through 90 days ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: Yes ]
  • Stress Testing-related Adverse Event [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: Yes ]
  • Length of stay [ Time Frame: Duration of Index Hospitalization ] [ Designated as safety issue: No ]
  • Acute coronary syndrome [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: Yes ]
  • Mortality [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: Yes ]
  • Stress testing-related adverse event [ Time Frame: Index Hospitalization through 90 days ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Randomized Investigation of Chest Pain Diagnostic Strategies
Randomized Investigation of Chest Pain Diagnostic Strategies

Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses 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 primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain.

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. Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses 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 and invasive procedures. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers. As a result, CMR could improve the care of emergency department (ED) patients with intermediate risk chest pain. However, the efficiency and safety of CMR has not been extensively tested in the CDU setting.

Primary Hypothesis: A CDU-CMR strategy will reduce the occurrence of the composite of revascularization, re-hospitalization, and recurrent cardiac testing at 90 days when compared to an inpatient care strategy.

Methods: Participants (n=146) at intermediate risk for acute coronary syndrome (ACS) will be recruited into a clinical trial from Wake Forest University Baptist Medical Center (WFUBMC) ED. Participants will be equally randomized to CDU-CMR or inpatient care. CDU-CMR participants will undergo resting and stress CMR imaging in parallel with serial cardiac markers. Inpatient care participants will undergo serial cardiac markers followed by existing cardiac testing as determined by their care providers. The primary outcome is the composite of 90 day revascularization, re-hospitalization, and recurrent cardiac testing. The secondary outcome is index hospitalization length of stay. Safety events include ACS after discharge, mortality, and stress testing-related adverse events.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
  • Acute Coronary Syndrome
  • Chest Pain
Other: Clinical decision unit care, coupled with cardiac MRI
After ED evaluation, patients are randomized to clinical decision unit care or inpatient care. Patients in the clinical decision unit will also undergo a stress cardiac MRI. Patients in the inpatient care arm may undergo any desired testing, including cardiac MRI, as determined by their treating physician.
  • No Intervention: Inpatient Care
    This is the comparison arm. Patients are admitted to the hospital and undergo usual care.
  • Experimental: CDU-CMR Protocol
    Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
    Intervention: Other: Clinical decision unit care, coupled with cardiac MRI

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
105
August 2012
October 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age greater than or equal to 21 years of age at the time of enrollment
  • Chest discomfort or other symptoms consistent with possible ACS as indicated by the treating physician after obtaining an ECG and cardiac biomarkers for the patient's evaluation
  • Thrombolysis in myocardial infarction (TIMI) risk score >/= 2 or physician impression of intermediate or high likelihood symptoms represent ACS
  • Patient requires an inpatient or CDU evaluation for their chest pain
  • The treating physician feels the patient could be discharged home if cardiac disease was excluded
  • The treating physician feels the patient is safe for CDU care

Pretest probability assessment The assessment of intermediate risk for developing ACS will be based on a TIMI risk score >/= 2 and / or a board certified / board eligible emergency physician clinical impression of intermediate or high likelihood that the symptoms represent ACS. Physicians are encouraged to use the 2007 American College of Cardiology (ACC)/American Heart Association (AHA) guidelines as a framework for this assessment.

Exclusion Criteria:

  • Elevated cardiac biomarkers
  • New ST-segment elevation on any electrocardiogram (>/= 1 mV)
  • New ST-segment depression on any electrocardiogram (>/= 2 mV)
  • Known inducible cardiac ischemia without subsequent revascularization
  • Unable to lie flat
  • Symptomatic hypotension at the time of enrollment (systolic < 90 mm Hg)
  • Contra-indications to MRI (examples: Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, severe claustrophobia)
  • Patient refusal or inability to comply with medical record review and follow up
  • Terminal diagnosis with life expectancy less than 3 months
  • Currently Pregnant
  • Creatinine clearance < 45 ml/min at the time of enrollment or clinical concern for acute kidney injury
  • Chronic liver disease with a creatinine clearance of <60 ml/min at the time of enrollment
  • Hepato-renal syndrome
  • History of liver, heart, or kidney transplant
  • Confirmed angioplasty, stent placement, or coronary artery bypass grafting (CABG) within the last 6 months
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01035047
IRB00010410, 1R21HL097131-01A1
Yes
Chadwick Miller, MD, Wake Forest University Baptist Medical Center
Wake Forest Baptist Health
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Chadwick Miller, M.D. WFUBMC
Wake Forest Baptist Health
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP