Clinical trial NCT00849108: Development of 1-Day Rest/Stress Cardiac PET Perfusion Imaging Protocol of BMS747158
Official title: A Phase 2, Open-Label, Randomized Multicenter Study for the Development of One-Day Rest/Stress Cardiac Positron Emission Tomography (PET) Perfusion Imaging Protocols of BMS747158
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ischemia
Keywords: Myocardial Perfusion
PET imaging
SPECT imaging
Coronary artery disease
Subjects that are male and nonpregnant female patients
presenting with reversible ischemia as characterized by a
rest/stress SPECT imaging study using
Technetium(99mTc)-labeled tracers
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2009-02-23
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The main purpose of this study is to get more information on using BMS747158 (the study drug),a drug with small amounts of radioactivity to allow for heart imaging, during a PET scan which can then be compared to other images such as SPECT. The safety and quality of images will be studied.

Detailed description: The primary objectives of this study are:

* To acquire data for the development of one-day rest/stress cardiac PET perfusion imaging protocols for BMS747158 with comparable diagnostic image quality to a two-day rest/stress PET protocol
* To assess the safety of multiple doses of BMS747158

The secondary objectives of this study are:

* To assess PET imaging parameters and image quality following administration of BMS747158 at rest and at stress (pharmacologic or exercise) same day (at different time intervals) and 16-48 hours after the rest injection
* To assess feasibility of gated cardiac PET imaging with BMS747158 for left ventricular function assessment
* To assess agreement of one and two day rest/stress PET imaging with BMS747158 in patients with reversible ischemia with rest/stress single photon emission computed tomography (SPECT) imaging
* To perform a preliminary assessment of the diagnostic accuracy of one-day and two-day rest/stress PET perfusion imaging with BMS747158 as compared with invasive coronary angiography or computed tomography angiography (CTA) for detection of

Eligibility criteria: Inclusion Criteria:

* Provide signed IC prior to undergoing any study procedures
* Be male or nonpregnant female, between the ages of 18 to 75 years, inclusive
* Have:A rest/stress SPECT imaging study (either exercise or pharmacologic stress) within 21 days of enrollment, using 99mTc-labeled tracers and showing reversible ischemia
* Female patients must:

  * be nonlactating,
  * no longer have child-bearing potential, either because they are post-menopausal (defined as amenorrhea ≥ 12 consecutive months, or because they have undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy)

Exclusion Criteria:

* Presence of any condition that may disrupt and/or increase permeability of the BBB, including multiple sclerosis, Alzheimer's disease, Parkinson's disease, acute central nervous system (CNS) infection, CNS tumor, autoimmune disease affecting the CNS, or CNS inflammatory
* Current significant illness, pathology or physical examination or vital signs measurement-findings that could potentiate any adverse pharmacological event associated with a vasodilatory drug or any pathology that, in the opinion of the investigator, might confound the interpretation of the results of the study
* Known hypersensitivity to adenosine, dipyridamole or aminophylline
* Presence of any contraindications to exercise stress testing
* History of New York Heart Association Class III or IV Congestive Heart Failure (CHF)
* Any major surgery within 4 weeks prior to enrollment or planned within 2 weeks following completion of the 2-week telephone follow-up assessment
* Inability to tolerate IV medication.
* History of drug or alcohol abuse within the last year
* Participation in any investigational drug, device, or placebo study within 6 months prior to study enrollment

Primary outcomes:
measure: Cohort 1: Determination of Rest Dose: Dose Acquistion Time Product
timeFrame: Dosing visit
measure: Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Sensitivity (SN) vs SPECT MPI Sensitivity
timeFrame: Dosing visit
measure: Cohort 1: Determination of Ratio of Stress Dose to Rest Dose
timeFrame: Dosing visit
measure: Cohort 2: Diagnostic Efficacy of One-day Rest/Stress BMS747158 PET MPI Specificity (SP) vs SPECT MPI Specificity
timeFrame: Dosing Visit
Secondary outcomes:
Other outcomes:
Locations:
city: Fremont
country: United States
facility: Silicon Valley Medical Imaging
state: California
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA Medical Plaza
state: California
city: Sacramento
country: United States
facility: Radiological Associates of Sacramento
state: California
city: San Diego
country: United States
facility: VA Healthcare System San Diego
state: California
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Ayer
country: United States
facility: Primary Care Cardiology Research, Inc
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kansas City
country: United States
facility: Cardiovascular Consultants
state: Missouri
city: St. Louis
country: United States
facility: Saint Louis University
state: Missouri
city: St. Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Newark
country: United States
facility: University of Medicine and Dentistry of New Jersey
state: New Jersey
city: Teaneck
country: United States
facility: Holy Name Hospital
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Cleveland
country: United States
facility: University Hospital Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: Midwest Cardiology Research Foundation
state: Ohio
city: Johnson City
country: United States
facility: Mountain States Health Alliance
state: Tennessee
city: Knoxville
country: United States
facility: East Tennessee Clinical Research Institute
state: Tennessee
Study officials:
affiliation: Lantheus Medical Imaging
name: Cesare Orlandi, MD
role: STUDY_DIRECTOR
References:
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citation: Henzlova MJ, Cerqueira MD, Mahmarian JJ, Yao SS; Quality Assurance Committee of the American Society of Nuclear Cardiology. Stress protocols and tracers. J Nucl Cardiol. 2006 Nov;13(6):e80-90. doi: 10.1016/j.nuclcard.2006.08.011. No abstract available.
citation: Miyamoto MI, Vernotico SL, Majmundar H, Thomas GS. Pharmacologic stress myocardial perfusion imaging: a practical approach. J Nucl Cardiol. 2007 Apr;14(2):250-5. doi: 10.1016/j.nuclcard.2007.01.006. No abstract available.