Ignite Creation Date:
2024-05-05 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00486447
Status:
TERMINATED
Last Update Posted:
2017-08-23
First Post:
2007-06-12
Brief Title:
Perfusion Imaging and CT -Understanding Relative Efficacy
Sponsor:
GE Healthcare
Organization:
GE Healthcare
Study Overview
Official Title:
A Prospective Multi-center Study Comparing Cardiac Computed Tomography CT Using a 64-detector Row Volumetric Computed Tomography VCT Scanner for the Detection of Coronary Artery Disease With Cardiac Radionuclide Imaging
Status:
TERMINATED
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PICTURE
Brief Summary:
To determine the relative efficacy of Cardiac Computed Tomography Angiography CCTA and Single Positron Emission Computed Tomography SPECT in patients with an intermediate risk of CAD
Detailed Description:
This study is a prospective multi-center within-subject comparative study One hundred fifty 150 subjects with CATH procedures are needed in the study Approximately 300 subjects who meet all of the inclusionexclusion criteria will be enrolled The study population will consist of subjects with symptoms suspected of and at intermediate-risk for ischemic heart disease which are referred for MPS for a definitive diagnosis of CAD
Each subject will undergo the following procedures
A Myocardial Perfusion Study MPS procedure as standard of care
An IV contrast-enhanced cardiac CT CCTA procedure
A CATH procedure when the MPS andor cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians as a standard-of-care procedure
When both the MPS and CCTA are normal the subject is not required to undergo a CATH procedure but will enter into follow-up The research staff at each site will perform follow-up for each subject at 12 months 15 days and 24 months 15 days and 36 months 15 days after the completion of the cardiac CT procedure
Each subject will undergo the following procedures
A Myocardial Perfusion Study MPS procedure as standard of care
An IV contrast-enhanced cardiac CT CCTA procedure
A CATH procedure when the MPS andor cardiac CT examination is deemed positive or equivocal and at the discretion of the referring physicians as a standard-of-care procedure
When both the MPS and CCTA are normal the subject is not required to undergo a CATH procedure but will enter into follow-up The research staff at each site will perform follow-up for each subject at 12 months 15 days and 24 months 15 days and 36 months 15 days after the completion of the cardiac CT procedure
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