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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826773
• Other study ID #: CardioPET™ P-02
• Secondary ID: 2012-002261-36
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2013
• Last updated: March 8, 2017
• Start date: March 2013
• Est. completion date: September 2016

Study information

• Verified date: March 2017
• Source: Fluoropharma, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: September 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Belgium	Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst	Aalst
Belgium	Departement de Cardiologie, CU Saint-Luc	Bruxelles
Belgium	Service de Medicine Nucleaire, CHU Erasme	Bruxelles
Belgium	Nucleaire Geneesunde Gasthuisberg Leuven Hospital	Leuven
Belgium	Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium	Liege

Sponsors (1)

Lead Sponsor	Collaborator
Fluoropharma, Inc.

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™	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).	One year
Secondary	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	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	Baseline (pre-injection) values to Post-injection values

External Links

•   Click here for more information on CardioPET™