Ignite Creation Date:
2024-05-06 @ 1:46 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01890421
Status:
COMPLETED
Last Update Posted:
2018-05-16
First Post:
2013-06-27
Brief Title:
GadobutrolGadavist-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:
2018-04
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 1
Brief Summary:
Participants 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 participant in the study may range from 2 days to 4-6 weeks One to four visits to the study doctor will be required
This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging CMRI images regarding the detection sensitivity and exclusion specificity of coronary artery disease utilizing a uniform image acquisition software The CMR images will be tested either against the results from routine clinical Coronary Angiography CA or those from Computed Tomography Angiography CTA which is used as the standard of reference The CACTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 46 weeks after the study
CMRI and CACTA images will be collected for an independent image review blinded read
This study will investigate the diagnostic results of gadobutrol-enhanced Cardiac Magnetic Resonance Imaging CMRI images regarding the detection sensitivity and exclusion specificity of coronary artery disease utilizing a uniform image acquisition software The CMR images will be tested either against the results from routine clinical Coronary Angiography CA or those from Computed Tomography Angiography CTA which is used as the standard of reference The CACTA may have been performed up to 4 weeks prior to enrollment or be scheduled up to 46 weeks after the study
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 |
|---|---|---|---|
| 2012-002563-10 | EUDRACT_NUMBER | None | None |