Coronary artery disease MedDRA version: 17.0 Level: PT Classification code 10011078 Term: Coronary artery disease System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: CardioPET™
Pharmaceutical Form: Solution for injection
INN or Proposed INN: 18F-FCPHA
Concentration unit: MBq megabecquerel(s)
Concentration type: equal
Concentration number: 370-
Sponsors
FluoroPharma Medical
Eligibility
Sex/Gender
All
Inclusion 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 indicating =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.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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • 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 in known or suspected CAD subjects.. • To evaluate the safety of CardioPET™ in known or suspected CAD subjects. ;Secondary Objective: • A secondary objective is to assess fatty acid uptake at rest and following stress in known or suspected CAD subjects.;Primary end point(s): 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 MPI using coronary angiography as the standard of reference for the detection of CAD.;Timepoint(s) of evaluation of this end point: NA | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Laboratory Testing: hematology, serum chemistry and urine analysis, at baseline and 2-4 and 24 hour follow up. Electrocardiograms, Serial QT and QTc measurements at baseline, during procedure and at 2-4 and 24 hour follow up. Physical Examinations at baseline and 24 hour follow-up. Vital signs (heart rate and systolic and diastolic blood pressure ) at baseline and 2-4 and 24 hour follow up. Adverse Event Assessments. ;Timepoint(s) of evaluation of this end point: see E.5.2 | — |
Countries
Belgium
Outcome results
None listed