Evaluate the Effectiveness and Cost of Stress Cardiac Magnetic Resonance Imaging (MRI) for Non-invasive Evaluation of Lesions Discovered on Computed Tomography Angiography (CCTA) (DSTAT)
|ClinicalTrials.gov Identifier: NCT00538460|
Recruitment Status : Terminated (Lack of staff and funding.)
First Posted : October 2, 2007
Last Update Posted : March 1, 2010
|Condition or disease|
Non-invasive evaluation of coronary anatomy via multi-slice computed tomography with coronary CT angiography (CCTA) has been shown to provide rapid and accurate non-invasive coronary angiography. Although CCTA can be rapidly and safely performed and despite improving our ability to image coronary arteries in this noninvasive fashion, the limitation of CCTA is lack of physiological information in intermediate lesions, i.e., if a patient has a blockage of 40-60% on CCTA in an artery, it is not possible to know if this is what causes symptoms in a patient. This limitation is currently being overcome by stress testing, commonly with perfusion imaging (nuclear stress test). However, disadvantages of nuclear stress testing include long testing times (usually > 4 hours) and use of radiation. Patients with intermediate/uninterpretable lesions on CCTA will be randomized to MPI or MRI.
The endpoints of the study are:
Primary outcome variables:
1. Length of ED stay until definitive diagnosis (time from ED triage until definitive diagnosis).
Secondary outcome variables will include:
- Cost of care of an early diagnostic strategy utilizing stress CMR vs. standard care (costs incurred during index hospitalization and 30 day follow up period) in patients with intermediate lesions of CTA.
- Accuracy of CTA + stress CMR in prediction of occurrence of major adverse cardiac events (MACE) during a 3 month follow-up period, compared to the standard care (CTA + stress/rest MPI): cardiac death, acute myocardial infarction, need for coronary artery revascularization, need for admission or treatment for documented CAD.
|Study Type :||Observational|
|Actual Enrollment :||1 participants|
|Official Title:||Dual-Source CT and STress Cardiac Magnetic Resonance Assessment in the Triage of Patients With Suspected Acute Coronary Syndromes (D-STAT)|
|Study Start Date :||September 2007|
|Actual Primary Completion Date :||April 2009|
|Actual Study Completion Date :||April 2009|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538460
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||Kavitha Chinnaiyan, MD||William Beaumont Hospitals|
|Study Director:||Gilbert Raff, MD||William Beaumont Hospitals|