Clinical trial NCT01826773: CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects
Official title: A Phase II Open-Labeled Study to Evaluate CardioPET™ as a PET Imaging Agent for Evaluation of Myocardial Perfusion and Fatty Acid Uptake in Subjects With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease
Keywords: CardioPET
Coronary Artery Disease
Myocardial Perfusion Imaging
Coronary Angiography
Myocardial Fatty Acid Utilization
Lead sponsor: Fluoropharma, Inc.
Sponsor class: INDUSTRY
First posted: 2013-04-09
Enrollment: 34
Sex: ALL
Minimum age (years): 30
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™
timeFrame: One year
Secondary outcomes:
measure: 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
timeFrame: Baseline (pre-injection) values to Post-injection values
Other outcomes:
Locations:
city: Aalst
country: Belgium
facility: Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst
city: Bruxelles
country: Belgium
facility: Departement de Cardiologie, CU Saint-Luc
city: Bruxelles
country: Belgium
facility: Service de Medicine Nucleaire, CHU Erasme
city: Leuven
country: Belgium
facility: Nucleaire Geneesunde Gasthuisberg Leuven Hospital
city: Liege
country: Belgium
facility: Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium
Study officials:
affiliation: Nucleaire Geneesunde Gasthuisberg Leuven Hospital, Leuven, Belgium
name: Olivier Gheysens, Professor
role: PRINCIPAL_INVESTIGATOR
References: