A Study to Assess Regadenoson Administration Following an Inadequate Exercise Stress Test as Compared to Regadenoson Alone for Myocardial Perfusion Imaging (MPI) Using Single Photon Emission Computed Tomography (SPECT)

Completed · Phase 3

Conditions studied: Coronary Artery Disease (CAD)

In brief

The purpose of this study is to demonstrate that the strength of agreement between single photon emission computed tomography (SPECT) imaging with regadenoson following inadequate exercise stress testing and SPECT imaging with regadenoson alone is not inferior to the strength of agreement between two sequential regadenoson SPECT images without exercise.

Key facts

Study ID

NCT01618669

Run by

Astellas Pharma Global Development, Inc.

People needed

1147

Starts

2012-06-01

Expected to finish

2014-12-01

Last updated by the study team

2016-02-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects referred for an exercise or pharmacologic stress test SPECT MPI procedure for the evaluation of coronary artery disease (CAD) are eligible for study participation. Subjects referred for pharmacologic stress should have a reasonable potential of attempting exercise stress. Subject must have one of the following:
• a. Past ischemia on any prior imaging stress test without invasive intervention on the artery subtending this territory
• b. Subject with known CAD who have symptoms similar to previous ischemic symptoms, or recent onset of symptoms or recently worsened symptoms suggestive of ischemia
• c. Diamond Forrester estimated pretest probability of CAD of ≥ 50%
• d. History of most recent coronary artery bypass surgery or most recent percutaneous coronary intervention (PCI) > 10 years (patients who are > 30 days but less than 10 years post coronary artery bypass graft (CABG) or PCI can be included if they meet criteria a, b, or e)
• e. Previously demonstrated 100% occlusion by invasive coronary or computed tomography (CT) angiography without successful intervening revascularization as these foods may alter regadenoson effects

You may not qualify if…

• Subject has a clinically significant illness, medical condition, or laboratory abnormality
• Female subject who is pregnant or lactating
• Subject is on dialysis for end stage renal disease or has a history of glomerular filtration rate (GFR) < 15 mL/min (calculated using MDRD [Modification of Diet in Renal Disease] formula)
• Subject has a history of coronary revascularization by either PCI or CABG within 1 month prior to the rest myocardial perfusion imaging (MPI)
• Subject has a pacemaker or an implantable cardioverter defibrillator (ICD)
• Subject has a history of acute myocardial infarction (MI) or high risk unstable angina within 30 days prior to the rest MPI or has had cardiac transplantation
• Subject has uncontrolled hypertension at any point on Visit 2 prior to exercise testing (i.e., systolic blood pressure (SBP) ≥ 180 or diastolic blood pressure (DBP) ≥ 95 mmHg on two consecutive measurements while at rest).
• Subject has severe aortic stenosis or hypertrophic cardiomyopathy with obstruction or has decompensated congestive heart failure
• Subject has a history of severe respiratory disease including: asthma, chronic obstructive pulmonary disease (COPD) or other bronchospastic reactive airway disease or who is on 24-hour continuous oxygen

Where it is running

• Silicon Valley Medical Imaging — Fremont, California, United States
• Long Beach Memorial Medical Center — Long Beach, California, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• VA Greater Los Angeles Healthcare System — Los Angeles, California, United States
• Westside Medical Associates of Los Angeles — Los Angeles, California, United States
• Ventura Clinical Trials — Malibu, California, United States
• Mission Internal Medical Group — Mission Viejo, California, United States
• VA San Diego Healthcare System — San Diego, California, United States
• Santa Rosa Cardiology Medical Group, Inc. — Santa Rosa, California, United States
• Los Angeles Biomedical Research Institute — Torrance, California, United States
• HOCC - New Britain Campus — New Britain, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Alfieri Cardiology — Newark, Delaware, United States
• Delaware Clinical Trials — Wilmington, Delaware, United States
• Elite Research and Clinical Trials — Aventura, Florida, United States
• S & W Clinical Research — Fort Lauderdale, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Florida Heart Associates — Fort Myers, Florida, United States
• East Coast Institute for Research, LLC — Jacksonville, Florida, United States
• St. Luke's Cardiology St. Vincent's HealthCare — Jacksonville, Florida, United States
• Watson Medical Clinic/Lakeland Regional Medical Clinic — Lakeland, Florida, United States
• MIMA Century Research Associates — Melbourne, Florida, United States
• Cardiovascular Research Center of South Florida — Miami, Florida, United States
• Florida Hospital/Cardiovascular Institute — Orlando, Florida, United States
• Mobile Heart Specialists, PC — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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