Ignite Creation Date:
2024-05-06 @ 1:46 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01890434
Status:
COMPLETED
Last Update Posted:
2019-07-31
First Post:
2013-06-27
Brief Title:
Gadobutrol Gadavist-enhanced Cardiac Magnetic Resonance Imaging CMRI to Detect Coronary Artery Disease CAD
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
Multicenter Open-label Study to Evaluate Efficacy of Gadobutrol-enhanced Cardiac Magnetic Resonance Imaging CMRI for Detection of Significant Coronary Artery Disease CAD in Subjects With Known or Suspected CAD by a Blinded Image Analysis
Status:
COMPLETED
Status Verified Date:
2019-07
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:
GadaCAD 2
Brief Summary:
Subjects being evaluated for suspected or known Coronary artery Disease CAD based on signs andor symptoms will be invited to participate in the study The duration for a subject in the study may range from 2 days to 4-6 weeks One to four visits to the study doctor will be required
The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging CMRI exceed pre-specified minimum performance thresholds of 60 and 55 respectively and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator reststress for the detection of significant CAD The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography CA or Computed Tomography Angiography CTA which are the standard of reference
CMRI and CACTA images will be collected for an independent image review blinded read
The primary objective of this study is to demonstrate that sensitivity and specificity of gadobutrol-enhanced cardiac magnetic resonance imaging CMRI exceed pre-specified minimum performance thresholds of 60 and 55 respectively and to show superior sensitivity over unenhanced wall motion CMRI at vasodilator reststress for the detection of significant CAD The CMR images acquired with a uniform imaging acquisition software will be evaluated either against the results from routine clinical Coronary Angiography CA or Computed Tomography Angiography CTA which are the standard of reference
CMRI and CACTA images will be collected for an independent image review blinded read
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2013-000066-11 | EUDRACT_NUMBER | None | None |