Acute Coronary Syndrome, Chest Pain
Conditions
Keywords
Acute Coronary Syndrome, Chest pain, Cardiac MRI, Risk Stratification, Emergency Department
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.
Interventions
OTHERClinical 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.
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. | Index Hospitalization through 90 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred in the Emergency Department (ED) at Wake Forest Baptist Medical Center from March 2010 to June 2011.
Pre-assignment details
No participants were excluded from the trial prior to treatment assignment.
Participants by arm
| Arm | Count |
|---|---|
| CDU-CMR Protocol Patients will be transferred to the clinical decision unit and undergo a stress cardiac MRI evaluation.
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. | 52 |
| Inpatient Care This is the comparison arm. Patients are admitted to the hospital and undergo usual care. | 53 |
| Total | 105 |
Baseline characteristics
| Characteristic | CDU-CMR Protocol | Inpatient Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 15 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 38 Participants | 81 Participants |
| Age, Continuous | 54 years | 59 years | 56 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 0 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 53 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 20 Participants | 15 Participants | 35 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 30 Participants | 38 Participants | 68 Participants |
| Sex: Female, Male Female | 24 Participants | 24 Participants | 48 Participants |
| Sex: Female, Male Male | 28 Participants | 29 Participants | 57 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 18 / 52 | 17 / 53 |
| serious Total, serious adverse events | 14 / 52 | 15 / 53 |
Outcome results
Primary
The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days.
Time frame: Index Hospitalization through 90 days
Population: Data from all participants was used in the primary outcome analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDU-CMR Protocol | The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. | 7 participants |
| Inpatient Care | The Composite of Revascularization, Re-hospitalization, and Recurrent Cardiac Testing Through 90 Days. | 20 participants |
Secondary
Acute Coronary Syndrome
Time frame: Index Hospitalization discharge through 90 days
Population: Data from all participants was used in outcome analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDU-CMR Protocol | Acute Coronary Syndrome | 0 participants |
| Inpatient Care | Acute Coronary Syndrome | 3 participants |
Secondary
Length of Stay
Time frame: Duration of Index Hospitalization, an average of 1-2 days
Population: Data from all participants was used in outcome analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| CDU-CMR Protocol | Length of Stay | 21.1 hours |
| Inpatient Care | Length of Stay | 26.3 hours |
Secondary
Mortality
Time frame: Index Hospitalization through 90 days
Population: Data from all participants was used for outcome analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDU-CMR Protocol | Mortality | 0 participants |
| Inpatient Care | Mortality | 0 participants |
Secondary
Stress Testing-related Adverse Event
Time frame: Index Hospitalization through 90 days
Population: Data from all participants was used for outcome analysis
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CDU-CMR Protocol | Stress Testing-related Adverse Event | 1 participants |
| Inpatient Care | Stress Testing-related Adverse Event | 0 participants |