Coronary Artery Disease
Conditions
Keywords
CardioPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Coronary Angiography, Myocardial Fatty Acid Utilization
Brief summary
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.
Detailed description
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.
Interventions
DRUGCardioPET™
CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).
Sponsors
Fluoropharma, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects must provide written informed consent prior to any study related procedures; * Male and female subjects over 30 years of age with known or suspected CAD; * Subjects have been evaluated as having known or suspected CAD by either exercise or pharmacologic MPI or echocardiography with ≥2 segments of ischemia and have been referred to coronary angiography for known or suspected CAD; * Subjects must be able to complete all evaluations within 30 days of Tc-99m MPI imaging, and must be without any intervention or change in symptoms between the tests.
Exclusion criteria
* Past or present use of medications that target fatty acid uptake or metabolism, e.g. Ranexa® (Ranolazine); * Acute changes in comparison to most recent ECG; * Suspected acute coronary syndrome; * Chronic renal failure (Cr \> 2.5); * Anemia (Hgb \< 10 within past 2 weeks); * NYHA Class III or IV Congestive heart failure; * Severe heart valve disease; * Any exposure to any investigational drugs or devices, within 30 days prior to imaging study; * Any acute or unstable physical or psychological disease judged by the Investigators based on medical history or screening physical examination; Female subjects only: * Subject that has a positive pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing. * Females not of child-bearing potential require confirmatory documentation in their medical records or must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days following CardioPET™ administration. Male subjects: * Reliable contraception method from the first injection with the tracer until 3 months after the last injection with the tracer. The following contraceptive method(s) is (are) allowed during the study: Condom. * If your partner becomes pregnant during the study, you should immediately report this to the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™ | One year | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Baseline (pre-injection) values to Post-injection values | * 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 |
Countries
Belgium
Outcome results
None listed