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Randomized Investigation of Chest Pain Diagnostic Strategies

Primary Purpose

Acute Coronary Syndrome, Chest Pain

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Clinical decision unit care, coupled with cardiac MRI

About this trial

This is an interventional diagnostic trial for Acute Coronary Syndrome focused on measuring Acute Coronary Syndrome, Chest pain, Cardiac MRI, Risk Stratification, Emergency Department

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Wake Forest University Baptist Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Inpatient Care

CDU-CMR Protocol

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Length of Stay

Acute Coronary Syndrome

Mortality

Stress Testing-related Adverse Event

Full Information

NCT ID

NCT01035047

First Posted

December 17, 2009

Last Updated

August 10, 2018

Sponsor

Wake Forest University Health Sciences

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT01035047

Brief Title

Randomized Investigation of Chest Pain Diagnostic Strategies

Official Title

Randomized Investigation of Chest Pain Diagnostic Strategies

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

October 2011 (Actual)

Study Completion Date

August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Wake Forest University Health Sciences

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Coronary Syndrome, Chest Pain

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

105 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Inpatient Care

Arm Type

No Intervention

Arm Description

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

Arm Title

CDU-CMR Protocol

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Clinical decision unit care, coupled with cardiac MRI

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Time Frame

Index Hospitalization through 90 days

Secondary Outcome Measure Information:

Title

Length of Stay

Time Frame

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

Title

Acute Coronary Syndrome

Time Frame

Index Hospitalization discharge through 90 days

Title

Mortality

Time Frame

Index Hospitalization through 90 days

Title

Stress Testing-related Adverse Event

Time Frame

Index Hospitalization through 90 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chadwick Miller, M.D.

Organizational Affiliation

WFUBMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

Wake Forest University Baptist Medical Center

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

12. IPD Sharing Statement

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Randomized Investigation of Chest Pain Diagnostic Strategies

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