Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-02-25 @ 5:33 PM
Study NCT ID:
NCT00538460
Status:
TERMINATED
Last Update Posted:
2010-03-01
First Post:
2007-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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:
Corewell Health East
Organization:
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, 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:
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 + stress/rest MPI): cardiac death, acute myocardial infarction, need for coronary artery revascularization, need for admission or treatment for documented CAD.
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 + stress/rest MPI): cardiac death, acute myocardial infarction, need for coronary artery revascularization, need for admission or treatment for documented CAD.
Study Oversight
Has Oversight DMC:
True
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?: