Coronary Artery DiseasePhase 2NCT01826773
CardioPET as PET Imaging Agent to Assess Myocardial Perfusion and Fatty Acid Uptake in Known or Suspected CAD Subjects
A Phase 2 study testing CardioPET™ in people with Coronary Artery Disease, run by Fluoropharma, Inc. at 5 sites in Belgium.
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- CardioPET™
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 5 sitesBelgium
- Study dates
- Mar 2013to Sep 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Belgium5 sites
Dienst Nucleaire Geneeskunde, OLV Ziekenhuis Aalst
Aalst
Departement de Cardiologie, CU Saint-Luc
Brussels
Service de Medicine Nucleaire, CHU Erasme
Brussels
Nucleaire Geneesunde Gasthuisberg Leuven Hospital
Leuven
Service de Medicine Nucleaire, Centre Hospitalier Univerisataire de Liege, Belgium
Liège
About this study
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
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.
Read the 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
- Being tested
- CardioPET™
- Keywords
- CardioPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Coronary Angiography, Myocardial Fatty Acid Utilization
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioPET™Drug
Also called trans-9-18F-Fluoro-3,4-Methyleneheptadecanoic Acid, FCPHA (Fluoro CycloPropyl Hexadecanoic Acid)
CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).
| Study group | Role | What they receive |
|---|---|---|
| Stress only CardioPET™ | Experimental | 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. Receives: Drug: CardioPET™ |
| Rest only CardioPET™ | Experimental | 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. Receives: Drug: CardioPET™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One year
Secondary outcomes (1)
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
Measured: Baseline (pre-injection) values to Post-injection values
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fluoropharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Olivier Gheysens, Professor, Principal investigator, Nucleaire Geneesunde Gasthuisberg Leuven Hospital, Leuven, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826773
- Sponsor's protocol ID
- CardioPET™ P-02
- Other IDs
- 2012-002261-36
- Status last verified
- Mar 2017
- First submitted
- 4 Apr 2013
- Last updated
- 10 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01826773
- Acronym / sponsor ID
- CardioPET™ P-02
- Conditions
- Coronary Artery Disease
- Keywords
- CardioPET, Coronary Artery Disease, Myocardial Perfusion Imaging, Coronary Angiography, Myocardial Fatty Acid Utilization
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Fluoropharma, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2013 (actual)
- Primary completion
- Jul 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stress only CardioPET™ | Experimental | Drug: 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. |
| Rest only CardioPET™ | Experimental | Drug: 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. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioPET™Also: trans-9-18F-Fluoro-3,4-Methyleneheptadecanoic Acid, FCPHA (Fluoro CycloPropyl Hexadecanoic Acid)CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq). | Drug | Rest only CardioPET™, Stress only CardioPET™ |
Primary outcome
Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™
Time frame: One year
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).
1 secondary outcome
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
Time frame: Baseline (pre-injection) values to Post-injection values
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2017.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Gheysens, Professor principal investigator
Nucleaire Geneesunde Gasthuisberg Leuven Hospital, Leuven, Belgium
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CardioPET™ in people with Coronary Artery Disease, run by Fluoropharma, Inc. at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint- sensitivity and specificity of CardioPET™ (time frame: One year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.