Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
NCT ID: NCT00869245
Last Updated: 2017-11-08
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
124 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-03-31
Study Completion Date
2011-10-31
Brief Summary
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The purpose of this study is to investigate the best way to evaluate patients with chest pain in the emergency department. It compares types of cardiac tests performed while receiving treatment in an observation unit. Patients will either undergo cardiac MRI testing or conventional care testing. Patients treated in the conventional care testing group will undergo the testing their doctor determines is best for them. All patients will undergo follow up to find out if they have had any heart related events.
Detailed Description
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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. Observation units (OU) improve resource utilization, are endorsed by the ACC/AHA guidelines, but have seen limited implementation in non-low risk chest pain patients due to limitations 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 resulting from false positive results. The high sensitivity for ongoing ischemia could allow imaging in parallel with cardiac markers.
Research hypotheses:
OU-CMR will have superior therapeutic efficacy to OU-conventional testing.
An OU-CMR strategy will have higher diagnostic thinking efficacy than OU-conventional testing.
Methods summary:
To address the question of feasibility of a CMR approach to managing patients at intermediate risk for ACS, we propose a randomized clinical trial of 120 patients at intermediate risk of ACS that present to the ED of Wake Forest University Baptist Medical Center (WFUBMC) for evaluation of chest pain. All patients will receive care in an OU, and will be randomized to CMR, or conventional testing. CMR participants will undergo cardiac markers and CMR testing; conventional testing participants will undergo serial cardiac markers followed by conventional cardiac testing. ACS (infarction, death, coronary revascularization, unstable angina) will be assessed by evaluation of hospital course and phone follow-up at 30 days. Cost of hospital care will be compared among groups.
Research hypotheses:
OU-CMR will have superior therapeutic efficacy to OU-conventional testing.
An OU-CMR strategy will have higher diagnostic thinking efficacy than OU-conventional testing.
Methods summary:
To address the question of feasibility of a CMR approach to managing patients at intermediate risk for ACS, we propose a randomized clinical trial of 120 patients at intermediate risk of ACS that present to the ED of Wake Forest University Baptist Medical Center (WFUBMC) for evaluation of chest pain. All patients will receive care in an OU, and will be randomized to CMR, or conventional testing. CMR participants will undergo cardiac markers and CMR testing; conventional testing participants will undergo serial cardiac markers followed by conventional cardiac testing. ACS (infarction, death, coronary revascularization, unstable angina) will be assessed by evaluation of hospital course and phone follow-up at 30 days. Cost of hospital care will be compared among groups.
Conditions
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Acute Coronary Syndrome
Chest Pain
Keywords
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ACS
Acute Coronary Syndrome
Chest pain
Cardiac MRI
CMR
Risk Stratification
Emergency Department
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
SINGLE
Outcome Assessors
Study Groups
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1
Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
Group Type
EXPERIMENTAL
OU - Cardiac MRI
Intervention Type
OTHER
During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.
2
Conventional care cardiac testing. Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.
Group Type
EXPERIMENTAL
OU - Conventional Care Testing
Intervention Type
OTHER
Patients in the conventional testing arm will undergo testing as determined by their treating physician.
Interventions
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OU - Cardiac MRI
During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.
Intervention Type
OTHER
OU - Conventional Care Testing
Patients in the conventional testing arm will undergo testing as determined by their treating physician.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
* Age greater than or equal to 18 years
* Chest discomfort or other symptoms consistent with possible ACS
* TIMI risk score ≥ 1 or physician impression\* of intermediate or high likelihood symptoms represent ACS
* Patient requires an inpatient or observation unit evaluation for their chest pain
* The treating physician feels the patient could be discharged home if cardiac disease was excluded
* ED attending feels patient is safe for observation unit care\*\*
* Chest discomfort or other symptoms consistent with possible ACS
* TIMI risk score ≥ 1 or physician impression\* of intermediate or high likelihood symptoms represent ACS
* Patient requires an inpatient or observation unit evaluation for their chest pain
* The treating physician feels the patient could be discharged home if cardiac disease was excluded
* ED attending feels patient is safe for observation unit care\*\*
Exclusion Criteria
* Initial troponin I \> 1.0 ng/ml
* New ST-segment elevation (≥1mV) or depression (≥2 mV)
* Contra-indications to MRI (listed below)
* Unable to lie flat
* Hypotension (systolic \< 90 mm Hg)
* Renal insufficiency (estimated GFR \< 45 cc/min) or end stage renal disease
* Life expectancy less than 3 months
* Patient refusal of medical record review and follow-up at 30 days
* Pregnancy
* Liver, heart, or kidney transplant
* Chronic liver disease
* Unable to speak English or Spanish
* The ED attending feels that cardiac catheterization is indicated
* The ED care provider intends to order a CT coronary angiogram
(\*)Physicians are encouraged to use the 2007 ACC/AHA guidelines for the management of patients with NSTE ACS as a framework for this assessment.(1)
(\*\*)These patients should generally not be considered for observation unit care: PCI / CAGB in past 6 months, multiple stents, multiple prior MIs
Contraindications to MRI: (Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia)
* New ST-segment elevation (≥1mV) or depression (≥2 mV)
* Contra-indications to MRI (listed below)
* Unable to lie flat
* Hypotension (systolic \< 90 mm Hg)
* Renal insufficiency (estimated GFR \< 45 cc/min) or end stage renal disease
* Life expectancy less than 3 months
* Patient refusal of medical record review and follow-up at 30 days
* Pregnancy
* Liver, heart, or kidney transplant
* Chronic liver disease
* Unable to speak English or Spanish
* The ED attending feels that cardiac catheterization is indicated
* The ED care provider intends to order a CT coronary angiogram
(\*)Physicians are encouraged to use the 2007 ACC/AHA guidelines for the management of patients with NSTE ACS as a framework for this assessment.(1)
(\*\*)These patients should generally not be considered for observation unit care: PCI / CAGB in past 6 months, multiple stents, multiple prior MIs
Contraindications to MRI: (Pacemaker, defibrillator, cerebral aneurysm clips, metallic ocular foreign body, implanted devices, claustrophobia)
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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American Heart Association
OTHER
Sponsor Role
collaborator
Wake Forest University Health Sciences
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Chadwick Miller, M.D.
Role: PRINCIPAL_INVESTIGATOR
WFUBMC
Locations
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Wake Forest University Baptist Medical Center - Emergency Department
Winston-Salem, North Carolina, United States
Site Status
Countries
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United States
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DERIVED
Other Identifiers
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AHA Identification # 0980008N
Identifier Type: -
Identifier Source: secondary_id
IRB00008247
Identifier Type: -
Identifier Source: org_study_id