CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects

• Status: Completed
• Trial end date: 2016-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fluoropharma, Inc.
• Treatments: Palmitic Acid

Criteria

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.