Ignite Creation Date:
2024-05-05 @ 11:26 PM
Last Modification Date:
2024-10-26 @ 10:34 AM
Study NCT ID:
NCT01334918
Status:
COMPLETED
Last Update Posted:
2017-12-19
First Post:
2011-04-12
Brief Title:
A Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging MPI Using Multidetector Computed Tomography MDCT Compared to Single Photon Emission Computed Tomography SPECT
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
A Phase 2 Open-Label Randomized Cross-Over Study of Regadenoson in Subjects Undergoing Stress Myocardial Perfusion Imaging by Multidetector Computed Tomography MDCT and Single Photon Emission Computed Tomography SPECT
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:
The purpose of this study is to compare Multidetector Computed Tomography MDCT and Single Photon Emission Computed Tomography SPECT stress myocardial perfusion imaging MPI with regadenoson in order to detect the presence or absence of reversible defects
Detailed Description:
All participants will be randomized to one of two imaging sequences reststress SPECT on Day 1 followed by stressrest MDCT on Day 2 or stressrest MDCT on Day 1 followed by reststress SPECT on Day 2 All stress scans will involve the injection of regadenoson as the pharmacologic stress agent
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