|
|
Home
Search
Study Topics
Glossary
|
 |
|
|
|
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||||||||||||||
| Sponsors and Collaborators: |
Wake Forest University Baptist Medical Center American Heart Association |
|---|---|
| Information provided by: | Wake Forest University Baptist Medical Center |
| ClinicalTrials.gov Identifier: | NCT00869245 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Coronary Syndrome Chest Pain |
Other: OU - Cardiac MRI Other: OU - Conventional Care Testing |
| Study Type: | Interventional |
| Study Design: | Diagnostic, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Efficacy Study |
| Official Title: | Efficacy Evaluation of Observation Unit Cardiac Magnetic Resonance Imaging (MRI) in Patients With Intermediate Risk Acute Chest Pain |
| Estimated Enrollment: | 120 |
| Study Start Date: | March 2009 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Cardiac MRI Protocol. Patients will be transferred to the observation unit and undergo a stress cardiac MRI evaluation.
|
Other: OU - Cardiac MRI
During ED evaluation, patients are randomized to cardiac MRI or conventional care testing.
|
|
2: Experimental
Conventional care cardiac testing. Patients will be transferred to the observation unit and undergo cardiac testing as determined by their treating physician.
|
Other: OU - Conventional Care Testing
Patients in the conventional testing arm will undergo testing as determined by their treating physician.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
(*)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)
Contacts and Locations| Contact: Erin Harper, B.S. | 336-716-1740 | erharper@wfubmc.edu |
| Contact: Lori Triplett, R.N. | 336-716-1740 | ltriplet@wfubmc.edu |
| United States, North Carolina | |
| Wake Forest University Baptist Medical Center - Emergency Department | Recruiting |
| Winston-Salem, North Carolina, United States, 27157 | |
| Contact: Erin Harper, B.S. 336-716-2059 erharper@wfubmc.edu | |
| Principal Investigator: Chadwick Miller, M.D. | |
| Sub-Investigator: James Hoekstra, M.D. | |
| Sub-Investigator: Doug Case, PhD | |
| Sub-Investigator: Wenke Hwang, M.D. | |
| Sub-Investigator: W. Gregory Hundley, M.D. | |
| Principal Investigator: | Chadwick Miller, M.D. | WFUBMC |
More Information
| Responsible Party: | Wake Forest University Baptist Medical Center ( Chadwick Miller, MD ) |
| Study ID Numbers: | IRB00008247, AHA Identification # 0980008N |
| Study First Received: | March 24, 2009 |
| Last Updated: | April 2, 2009 |
| ClinicalTrials.gov Identifier: | NCT00869245 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
ACS Acute Coronary Syndrome Chest pain Cardiac MRI |
CMR Risk Stratification Emergency Department |
|
Signs and Symptoms Heart Diseases Myocardial Ischemia Acute Coronary Syndrome Vascular Diseases |
Emergencies Pain Ischemia Chest Pain |
|
Signs and Symptoms Heart Diseases Pathologic Processes Disease Myocardial Ischemia Syndrome |
Acute Coronary Syndrome Vascular Diseases Cardiovascular Diseases Pain Chest Pain |
