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

NCT ID: NCT01826773

Last Updated: 2017-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2016-09-30

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.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Stress only CardioPET™

Group I will consist of 15-20 patients and will have CardioPET™ imaging performed with a repeat identical stress component at ≥ 48 hours and ≤ 10 days after the initial stress MPI study. There should be no intervention or change in symptoms between the tests, and the patient must have an angiography scheduled to be performed within 30 days.

The analysis of the acquired imaging data will determine if CardioPET™ is suitable for identifying myocardial flow defects that were observed in exercise or pharmacologic stress Tc-99m MPI imaging. The goal for this CardioPET™ imaging group is to measure blood flow at near maximal stress.

Group Type: EXPERIMENTAL

CardioPET™

Intervention Type: DRUG

CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).

Rest only CardioPET™

Group II will consist of 15-20 subjects will have undergone either, stress, Tc-99m MPI study or stress-echocardiography indicating ≥2 segments of ischemia. These patients must have been referred and scheduled for coronary angiography. If initial evaluation was performed with stress echocardiography, subjects will have either exercise or pharmacologic stress MPI.

CardioPET™ imaging in these subjects must be performed ≥ 48 hours and ≤ 10 days from the initial stress (stress MPI or echocardiography) at rest only. An angiography must be scheduled to be performed within 30 days.

Group Type: EXPERIMENTAL

CardioPET™

Intervention Type: DRUG

CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).

Interventions

CardioPET™

CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).

Intervention Type: DRUG

Other Intervention Names

trans-9-18F-Fluoro-3,4-Methyleneheptadecanoic Acid; FCPHA (Fluoro CycloPropyl Hexadecanoic Acid)

Eligibility 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.

• Minimum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fluoropharma, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier Gheysens, Professor

Role: PRINCIPAL_INVESTIGATOR

Nucleaire Geneesunde Gasthuisberg Leuven Hospital, Leuven, Belgium

Locations

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

Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium

Liège, , Belgium

Countries

Belgium

Related Links

http://www.fluoropharma.com/

Click here for more information on CardioPET™

Other Identifiers

2012-002261-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CardioPET™ P-02

Identifier Type: -

Identifier Source: org_study_id