Viewing Study NCT00538460



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Study NCT ID: NCT00538460
Status: TERMINATED
Last Update Posted: 2010-03-01
First Post: 2007-10-01

Brief Title: Evaluate the Effectiveness and Cost of Stress Cardiac Magnetic Resonance Imaging MRI for Non-invasive Evaluation of Lesions Discovered on Computed Tomography Angiography CCTA
Sponsor: William Beaumont Hospitals
Organization: William Beaumont Hospitals

Study Overview

Official Title: Dual-Source CT and STress Cardiac Magnetic Resonance Assessment in the Triage of Patients With Suspected Acute Coronary Syndromes D-STAT
Status: TERMINATED
Status Verified Date: 2010-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Lack of staff and funding
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: DSTAT
Brief Summary: This study is designed to evaluate the effectiveness and measurable cost impact of stress cardiac MRI for non-invasive evaluation of intermediate lesions discovered on CCTA in low-to-intermediate risk patients admitted to the ED with suspected ACS Our primary objective is to determine if the strategy of CTA stress CMR will reduce the length of time in the ED required to establish a definitive diagnosis compared to CTA stress MPI
Detailed Description: 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 ie 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 intermediateuninterpretable 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

1 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
2 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 stressrest MPI cardiac death acute myocardial infarction need for coronary artery revascularization need for admission or treatment for documented CAD

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None