Ignite Creation Date:
2024-05-05 @ 9:08 PM
Last Modification Date:
2024-10-26 @ 10:00 AM
Study NCT ID:
NCT00826280
Status:
COMPLETED
Last Update Posted:
2017-12-18
First Post:
2009-01-21
Brief Title:
Caffeines Effect on Regadenoson Administration With Single Photon Emission Computed Tomography SPECT Myocardial Perfusion Imaging MPI
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 3b Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Effect of Caffeine Intake on Single Photon Emission Computed Tomography SPECT Myocardial Perfusion Imaging MPI in Subjects Administered Regadenoson
Status:
COMPLETED
Status Verified Date:
2017-11
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:
Observe whether the administration of caffeine prior to regadenoson will affect the interpretation of test results in subjects with coronary artery disease CAD undergoing SPECT MPI
Detailed Description:
All subjects will undergo rest and stress scans Those subjects who qualify by demonstrating at least 1 reversible defect will undergo a third scan All stress scans will involve the injection of regadenoson as the pharmacologic stress agent Prior to the third scan the subject will be administered blinded capsules of placebo or caffeine
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