Status:
COMPLETED
CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects
Lead Sponsor:
Fluoropharma, Inc.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
30+ years
Phase:
PHASE2
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 musc...
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 myocar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01826773
Start Date
March 1 2013
End Date
September 1 2016
Last Update
March 10 2017
Active Locations (5)
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1
Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst
Aalst, Belgium
2
Departement de Cardiologie, CU Saint-Luc
Brussels, Belgium
3
Service de Medicine Nucleaire, CHU Erasme
Brussels, Belgium
4
Nucleaire Geneesunde Gasthuisberg Leuven Hospital
Leuven, Belgium