Randomized Investigation of Chest Pain Diagnostic Strategies

NCT01035047 | Completed Results DMC FDA Device

• 2 other identifiers: IRB000104101R21HL097131-01A1
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Coronary Syndrome; Chest Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.

  Index Hospitalization through 90 days

Secondary Outcomes (4)

• Length of Stay

  Duration of Index Hospitalization, an average of 1-2 days

• Acute Coronary Syndrome

  Index Hospitalization discharge through 90 days

• Mortality

  Index Hospitalization through 90 days

• Stress Testing-related Adverse Event

  Index Hospitalization through 90 days

Study Arms (2)

Inpatient Care

NO INTERVENTION

This is the comparison arm. Patients are admitted to the hospital and undergo usual care.

CDU-CMR Protocol

EXPERIMENTAL

Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.

Other: Clinical decision unit care, coupled with cardiac MRI

Interventions

Clinical decision unit care, coupled with cardiac MRI OTHER

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.

CDU-CMR Protocol

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Wake Forest University Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

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  PMID: 23664718 DERIVED

MeSH Terms

Conditions

Acute Coronary Syndrome; Chest Pain; Emergencies

Interventions

Family Characteristics

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

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics; Socioeconomic Factors; Epidemiologic Measurements; Public Health; Environment and Public Health

Results Point of Contact

• Title: Erin Harper
• Organization: Wake Forest Baptist Medical Center

erharper@wakehealth.edu

336-716-2059

Study Officials

• Chadwick Miller, M.D.

  WFUBMC

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: December 17, 2009
• First Posted: December 18, 2009
• Study Start: January 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: August 1, 2012
• Last Updated: September 10, 2018
• Results First Posted: November 29, 2012

Record last verified: 2018-08

Locations

US (1)