Ignite Creation Date:
2024-05-06 @ 1:58 AM
Last Modification Date:
2024-10-26 @ 11:12 AM
Study NCT ID:
NCT01949844
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2013-09-11
Brief Title:
Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
Sponsor:
Daniel S Berman
Organization:
Cedars-Sinai Medical Center
Study Overview
Official Title:
Artifact-Free High-resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a pilot study in a patient population with suspected coronary artery disease CAD as defined by the presence of a prior abnormal nuclear PETSPECT myocardial perfusion scan In this study design PETSPECT will serve as the comparative standard for presence of myocardial ischemia We intend to determine the accuracy of an improved magnetic resonance imaging MRI technique for detection of myocardial ischemia in subjects with suspected CAD
This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure
This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure
Detailed Description:
A total of two imaging protocols will be used as protocol options in this study only one of the protocols will be used for each enrolled subject 1 Two-day protocol which involves MRI of subjects who have had a recent abnormal PETSPECT study and includes an optional second-day visit 2 One-day protocol which involves the subjects undergoing stress myocardial perfusion SPECT and MRI in the same day
Two blinded readers will interpret MR and SPECTPET studies by consensus to assess the presence of perfusion deficits at stress and rest
Two blinded readers will interpret MR and SPECTPET studies by consensus to assess the presence of perfusion deficits at stress and rest
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