Clinical trial 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease (CAD)
Keywords: pharmacologic stress
Coronary Artery Disease (CAD)
regadenoson
ischemia
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-04-13
Enrollment: 124
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

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: 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.

Eligibility criteria: Inclusion Criteria:

* Male subjects must be ≥ 45 years of age
* Female subjects must be ≥ 50 years of age
* Subject has met at least one of the following three criteria:

  * has a suspected (clinical impression) or known diagnosis of coronary artery disease (CAD) with typical angina that has been referred from nuclear cardiology lab schedule or cardiac computed tomography (CT) schedule
  * has stable symptoms with possible elective catheterization procedure scheduled and where further imaging may be beneficial;
  * has known CAD from a previous invasive coronary angiography (ICA) performed more than 12 weeks prior to screening who now present with new cardiac symptoms
* Subject has been referred for a clinically indicated myocardial perfusion imaging procedure or Cardiac CT procedure for suspected moderate or high risk CAD
* Subject must abstain from eating and drinking 30 minutes prior and 30 minutes post study drug administration
* Subject must abstain from smoking 3 hours prior and 8 hours post study drug administration
* Subject must abstain from any intake of methylxanthine-containing foods and beverages within 12 hours prior to Day 1 visit through the Day 3 Follow-Up Visit, as these foods may alter regadenoson effects. Subject is able to safely abstain from theophylline use for 12 hours prior to study drug administration

Exclusion Criteria:

* Subject is concurrently participating in another drug study or has received an investigational drug within 30 days prior to Screening
* Subject has a history of a clinically significant illness (other than CAD), medical condition, or laboratory abnormality, which would preclude participation in the study
* Subject has renal dysfunction demonstrated by a glomerular filtration rate (GFR) \< 45 mL/min (calculated using Cockroft-Gault formula Note: Subjects with a GFR 45-60 mL/min will undergo a hydration procedure
* Female subject who is pregnant, lactating or of childbearing potential that refuses to use a medically acceptable form of contraception until the Telephone Follow up Visit is complete
* Female subject has a positive pregnancy test prior to randomization
* Subject has a history of second or third degree heart block or sinus node dysfunction unless the subject has a functioning pacemaker
* Subject has symptomatic hypotension (temporary and reversible conditions that no longer exist are allowed)
* Subject is allergic or intolerant to aminophylline, nitroglycerin or metoprolol
* Subject is allergic or intolerant to regadenoson or any of its excipients
* Subject is unable or unwilling to comply with the procedure schedule
* Subject has previously enrolled in this study or was enrolled in another regadenoson study sponsored by Astellas
* Subject has atrial fibrillation or significant arrhythmias which may result in decreased image quality for the imaging studies (CT and SPECT)
* Subject has high heart rate (\> 65 beats per minute) and contra-indications to administer beta-blockers (severe chronic obstructive pulmonary disease (COPD) or asthma, second and third degree atrioventricular block)

Primary outcomes:
measure: Number of Participants With Reversible Defects
timeFrame: Day 1 and Day 2
Secondary outcomes:
measure: Overall Image Quality of Scans by Modality and Reviewer
timeFrame: Day 1 and Day 2
measure: Number of Participants With Reversible Defects in the Left Anterior Descending Coronary Artery (LAD)
timeFrame: Day 1 and Day 2
measure: Number of Participants With Reversible Defects in the Right Coronary Artery (RCA)
timeFrame: Day 1 and Day 2
measure: Number of Participants With Reversible Defects in the Left Circumflex Coronary Artery (LCX)
timeFrame: Day 1 and Day 2
measure: Number of Participants With Fixed Defects
timeFrame: Day 1 and Day 2
measure: Percentage of Participants With Two or More Ischemic Segments on SPECT, But Less on CT
timeFrame: Day 1 and Day 2
Other outcomes:
Locations:
city: Roseville
country: United States
facility: Sutter Roseville Medical Center
state: California
city: Torrance
country: United States
facility: Harbor UCLA Medical Center
state: California
city: Miami
country: United States
facility: Cardiovascular Research Center of South Florida
state: Florida
city: Miami
country: United States
facility: Baptist Hospital of Miami
state: Florida
city: Overland Park
country: United States
facility: Midwest Cardiology Associates, P.C.
state: Kansas
city: Auburn
country: United States
facility: Maine Research Associates
state: Maine
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Pittsfield
country: United States
facility: Berkshire Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Astellas Pharma Global Development
name: Senior Medical Director
role: STUDY_DIRECTOR
References:
citation: Cury RC, Kitt TM, Feaheny K, Akin J, George RT. Regadenoson-stress myocardial CT perfusion and single-photon emission CT: rationale, design, and acquisition methods of a prospective, multicenter, multivendor comparison. J Cardiovasc Comput Tomogr. 2014 Jan-Feb;8(1):2-12. doi: 10.1016/j.jcct.2013.09.004. Epub 2013 Oct 18.