The study is designed to evaluate how safe and how well an investigational imaging product CardioPET™ performs as compared to standard approved imaging products in assessing the function of heart muscle in coronary artery disease patients.
The open label, phase II, multi center, study objectives are as follows: * To evaluate the diagnostic performance of CardioPET™ in assessing myocardial perfusion as compared to standard Tc-99m myocardial perfusion agents with coronary angiography as the standard of reference for CAD. * To evaluate the safety of CardioPET™ in known or suspected CAD subjects. * A secondary objective is to assess fatty acid uptake at rest and following stress.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
34
CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).
Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst
Aalst, Belgium
Departement de Cardiologie, CU Saint-Luc
Brussels, Belgium
Service de Medicine Nucleaire, CHU Erasme
Brussels, Belgium
Nucleaire Geneesunde Gasthuisberg Leuven Hospital
Leuven, Belgium
Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™
The aim of this clinical protocol is to study CardioPET™ as a PET imaging agent for evaluation of myocardial perfusion in subjects with known or suspected CAD with a single injection of CardioPET™. The primary efficacy endpoint for this phase II study is the sensitivity and specificity of CardioPET™ compared to Myocardial Perfusion Imaging (MPI) using coronary angiography as the standard of reference for the detection of Coronary Artery Disease (CAD).
Time frame: One year
Primary safety endpoints comparing baseline (pre-injection) values to post-injection values for laboratory testing, electrocardiograms, serial QT, and QTc measurements, physical examinations, vital signs and adverse event assessments
* Laboratory Testing- hematology, serum chemistry and urine analysis * Electrocardiograms, Serial QT and QTc measurements * Physical Examinations * Vital signs-heart rate and systolic and diastolic blood pressure * Adverse Event Assessments o
Time frame: Baseline (pre-injection) values to Post-injection values
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Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium
Liège, Belgium