Randomized Investigation of Chest Pain Diagnostic Strategies

Completed · Not applicable

Conditions studied: Acute Coronary Syndrome, Chest Pain

In brief

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.

Key facts

Study ID

NCT01035047

Run by

Wake Forest University Health Sciences

People needed

105

Starts

2010-01-01

Expected to finish

2012-08-01

Last updated by the study team

2018-09-10

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Wake Forest University Baptist Medical Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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