Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain
| Status: | Completed |
|---|---|
| Conditions: | Angina, Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/10/2017 |
| Start Date: | March 2009 |
| End Date: | October 2011 |
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.
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.
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.
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.
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**
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)
We found this trial at
1
site
Winston-Salem, North Carolina 27157
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