NCT01334918

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)

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Astellas Pharma Inc · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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: rest/stress SPECT on Day 1 followed by stress/rest MDCT on Day 2 or stress/rest MDCT on Day 1 followed by rest/stress SPECT on Day 2. All stress scans will involve the injection of regadenoson as the pharmacologic stress agent.

Conditions

• Coronary Artery Disease (CAD)

Interventions

Type	Name	Description
DRUG	regadenoson	Administered by intravenous bolus.
RADIATION	technetium Tc99m sestamibi /technetium Tc99m tetrafosmin	Administered by intravenous infusion
RADIATION	Contrast	Administered by intravenous infusion.
PROCEDURE	Single Photon Emission Computed Tomography	Procedure/Surgery
PROCEDURE	Multidetector Computed Tomography	Procedure/Surgery

Timeline

• Start date: 2011-04-26
• Primary completion: 2012-07-02
• Completion: 2012-07-02
• First posted: 2011-04-13
• Last updated: 2024-12-04
• Results posted: 2013-09-18

Locations

11 sites across 1 country: United States