Randomized Investigation of Chest Pain Diagnostic Strategies

August 10, 2018 updated by: Wake Forest University Health Sciences
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. 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.

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.
Time Frame: Index Hospitalization through 90 days
Index Hospitalization through 90 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of Stay
Time Frame: Duration of Index Hospitalization, an average of 1-2 days
Duration of Index Hospitalization, an average of 1-2 days
Acute Coronary Syndrome
Time Frame: Index Hospitalization discharge through 90 days
Index Hospitalization discharge through 90 days
Mortality
Time Frame: Index Hospitalization through 90 days
Index Hospitalization through 90 days
Stress Testing-related Adverse Event
Time Frame: Index Hospitalization through 90 days
Index Hospitalization through 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Chadwick Miller, M.D., WFUBMC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 17, 2009

First Submitted That Met QC Criteria

December 17, 2009

First Posted (Estimate)

December 18, 2009

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00010410
  • 1R21HL097131-01A1 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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