Status:
COMPLETED
Comparison of Diagnostic Rest/Stress SPECT Results for Patients With Myocardial Ischemia and Infarction Using Myoview in Both Single and Dual Isotope Acquisition Approaches
Lead Sponsor:
GE Healthcare
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The study is designed to determine whether a dual isotope protocol is equivalent to a single isotope in the diagnosis of myocardial ischemia and infarction using MYOVIEW SPECT imaging.
Eligibility Criteria
Inclusion
- The subject is 18 years old or older.
- Male subjects or non-lactating female subjects, who are either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), postmenopausal (cessation of menses for more than 1 year), or for women of childbearing potential, the results of a serum or urine human chorionic gonadotropin pregnancy test, performed at screening within 24 hours before dosing (with the result known before investigational medicinal product administration) must be negative.
- The subject is able and willing to comply with study procedures (i.e., 1 SPECT imaging at Stress, 2 SPECT imagings at Rest) and signed and dated informed consent is obtained.
- The subject is suspected of or known of having CAD based on the subject's clinical signs, symptoms, or examinations .
- The subject is referred for Rest/Stress (exercise or pharmacological) MPS-SPECT for known or suspected CAD (as clinically required).
Exclusion
- The subject was previously included in this study.
- The subject received an IMP within 30 days before or is scheduled to receive one during or in the next 30 days after IMP administration.
- The subject has known allergies to any product used in this study or its constituents, including subjects who are not able to exercise and have contraindications to Adenosine (e.g., Asthmatics).
- The subject presents any clinically active, serious, life-threatening disease, with a life expectancy of less than 1 month.
- The subject has no contraindications to any of the study procedures (e.g. physical exercise) or the involved drugs (Myoview, Thallium-201, Adenosine or Dipyridamole) such as e.g. 2nd or 3rd degree AV-block, SS syndrome, bradycardia, bronchoconstrictive or bronchospastic lung disease.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
291 Patients enrolled
Trial Details
Trial ID
NCT00381316
Start Date
July 1 2006
End Date
December 1 2006
Last Update
December 5 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
GE Healthcare
Princeton, New Jersey, United States, 08540