Coronary Allograft Vasculopathy (CAV)M-CAVNCT05751915
Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy
An observational study of Coronary Allograft Vasculopathy (CAV), run by Genetesis Inc. at 1 site in United States.
Trial summary
Purpose: To show early feasibility of magnetocardiography (MCG) to identify coronary Cardiac positron emission tomography (PET) is the preferred non-invasive tests to assess for CAV and incorporation of quantitative myocardial blood flow (MBF) assessment improves diagnostic accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Allograft Vasculopathy (CAV)
- What is being tested?
- CardioFlux
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2023to 30 Jan 2024
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart transplant recipients are susceptible to developing coronary allograft vasculopathy (CAV), a disease that causes blockages in the arteries of the transplanted heart. CAV often progresses without symptoms, and transplant recipients undergo regular surveillance to detect CAV. Current tests used to detect CAV, such as invasive coronary angiography (ICA) and intravascular ultrasound (US) have clear limitations; in addition to being invasive with risk of complications, they are also expensive, time consuming, and require iodinated contrast, a concern in a population with high rates of kidney dysfunction. In addition, these tests may not be able to detect CAV in its early stages. Additionally, the diagnosis of CAV remains a challenge as angiography, the standard method for detecting focal plaques, lacks sensitivity in detecting CAV, and intravascular ultrasonography, a more sensitive method, lacks the ability to evaluate the entirety of the coronary arteries.
Who may be able to join
- ≥ 18 years of age at the time of enrollment
- Willing to provide written informed consent
- Completed cardiac PET within the last 2 weeks
- No changes to medication or intervention since the PET was completed
Who cannot join
- Patients unable to fit into device
- Patients unable to lie supine for 5 minutes
- Patients with implanted ferromagnetic objects above the costal margin of the rib cage (implanted pacemakers, cardioverter/defibrillators, infusion pumps, and/or neuro stimulators).
- NOTE: Sternotomy wires stents are acceptable
- Implanted pacemakers or cardioverter/defibrillators
- Implanted infusion pumps and/or neuro stimulators
- Severe claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Purpose: To show early feasibility of magnetocardiography (MCG) to identify coronary Cardiac positron emission tomography (PET) is the preferred non-invasive tests to assess for CAV and incorporation of quantitative myocardial blood flow (MBF) assessment improves diagnostic accuracy. Based on ISHLT criteria, the following have been proposed for diagnosis of CAV by PET:
Read the detailed description
Diagnosing CAV by PET with quantitative myocardial blood flow (MBF) 3 PET CAV 0: Normal perfusion with normal global stress (> 1.7 mL/min/g)
PET CAV 1: Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g and ejection fraction >45%) OR Single vessel perfusion defect with normal global stress MBF.
PET CAV 2/3: Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g) and ejection fraction < 45% OR Single vessel perfusion defect with abnormal global stress MBF (<1.7 mL/min/g) OR Multivessel perfusion defects
With these diagnostic criteria, PET CAV 0 has been shown to have a high negative predictive value for moderate to severe CAV by invasive coronary angiography, and PET CAV 2/3 has been shown to have a high positive predictive value for moderate to severe CAV and is associated with adverse events.
This study further examines the feasibility of MCG in identifying CAV in adult heart transplant recipients and compares those results to the current non-invasive standard using PET CAV scores. This will help determine whether MCG is a potential test for regular surveillance of CAV in transplant recipients.
- Conditions
- Coronary Allograft Vasculopathy (CAV)
- Being tested
- CardioFlux
- Keywords
- Magnetocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioFluxDevice
CardioFlux MCG is a process that observes incremental changes in the heart's electrical activity by the magnetic fields generated by these currents. These magnetic fields have been used for decades via electrocardiogram to help diagnose and treat both acute and chronic cardiac pathology. The CardioFlux device reaches the potential of this phenomenon by sensing a complete magnetic field map. It is equipped with a magnetic shielding chamber and can attenuate magnetic field noise by a factor of nearly 1500 which maximizes signal to noise ratio. CardioFlux is an easy to operate, noninvasive modality that can detect the presence of ischemic cardiac tissue in symptomatic patients in a less than 5-minute scan. The device uses the proprietary software called Faraday which processes MCG scans, create diagnostic functional images, and run analytics.
| Study group | Role | What they receive |
|---|---|---|
| PET CAV 0 | Normal perfusion with normal global stress (> 1.7 mL/min/g) Receives: Device: CardioFlux | |
| PET CAV 1 | Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g and ejection fraction >45%) OR Single vessel perfusion defect with normal global stress MBF. Receives: Device: CardioFlux | |
| PET CAV 2/3 | Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g) and ejection fraction < 45% OR Single vessel perfusion defect with abnormal global stress MBF (<1.7 mL/min/g) OR Multivessel perfusion defects v Receives: Device: CardioFlux |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the performance (diagnostic capabilities) of magnetocardiography in the diagnosis of coronary vasculopathy (CAV) as compared to PET as the currently accepted gold standard non-invasive tool.
Ability of MCG to identify CAV 0 in heart transplant patients as measured by sensitivity, specificity, positive predictive value, and negative predictive value.
Measured: 6 months
Secondary outcomes (1)
To determine whether MCG is able to differentiate between CAV 0, 1, and 2/3, and to correlate with absolute stress myocardial blood flow, global CFR (Coronary flow reserve), and LVEF (Left ventricular ejection fraction), as measured by cardiac PET
Differentiation between CAV 0, 1, and 2/3
Correlation of MCG with absolute stress myocardial blood flow
Correlation of MCG with global CFR
Correlation of MCG with LVEF
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2023
- Study start23 May 2023
- Primary completion30 Dec 2023 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Allograft Vasculopathy (CAV)Studies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Genetesis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Responsible party
- Sponsor
- Investigators
- Paul Cremer, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05751915
- Sponsor's protocol ID
- 10007
- Acronym
- M-CAV
- Status last verified
- Jul 2023
- First submitted
- 21 Feb 2023
- Last updated
- 11 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetocardiography as a Noninvasive Diagnostic Strategy for Identifying Coronary Allograft Vasculopathy
- ClinicalTrials.gov ID
- NCT05751915
- Acronym / sponsor ID
- M-CAV / 10007
- Conditions
- Coronary Allograft Vasculopathy (CAV)
- Keywords
- Magnetocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Genetesis Inc.Industry (pharma, biotech, devices)
- Collaborators
- The Cleveland Clinic
- Study start
- 23 May 2023 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 2 Mar 2023 (actual)
- 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.
Purpose: To show early feasibility of magnetocardiography (MCG) to identify coronary Cardiac positron emission tomography (PET) is the preferred non-invasive tests to assess for CAV and incorporation of quantitative myocardial blood flow (MBF) assessment improves diagnostic accuracy. Based on ISHLT criteria, the following have been proposed for diagnosis of CAV by PET:
Detailed description
Diagnosing CAV by PET with quantitative myocardial blood flow (MBF) 3 PET CAV 0: Normal perfusion with normal global stress (> 1.7 mL/min/g)
PET CAV 1: Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g and ejection fraction >45%) OR Single vessel perfusion defect with normal global stress MBF.
PET CAV 2/3: Normal perfusion with abnormal global stress MBF (<1.7 mL/min/g) and ejection fraction < 45% OR Single vessel perfusion defect with abnormal global stress MBF (<1.7 mL/min/g) OR Multivessel perfusion defects
With these diagnostic criteria, PET CAV 0 has been shown to have a high negative predictive value for moderate to severe CAV by invasive coronary angiography, and PET CAV 2/3 has been shown to have a high positive predictive value for moderate to severe CAV and is associated with adverse events.
This study further examines the feasibility of MCG in identifying CAV in adult heart transplant recipients and compares those results to the current non-invasive standard using PET CAV scores. This will help determine whether MCG is a potential test for regular surveillance of CAV in transplant recipients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PET CAV 0 | – | Device: CardioFluxNormal perfusion with normal global stress (> 1.7 mL/min/g) |
| PET CAV 1 | – | Device: CardioFluxNormal perfusion with abnormal global stress MBF (<1.7 mL/min/g and ejection fraction >45%) OR Single vessel perfusion defect with normal global stress MBF. |
| PET CAV 2/3 | – | Device: CardioFluxNormal perfusion with abnormal global stress MBF (<1.7 mL/min/g) and ejection fraction < 45% OR Single vessel perfusion defect with abnormal global stress MBF (<1.7 mL/min/g) OR Multivessel perfusion defects v |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart transplant recipients are susceptible to developing coronary allograft vasculopathy (CAV), a disease that causes blockages in the arteries of the transplanted heart. CAV often progresses without symptoms, and transplant recipients undergo regular surveillance to detect CAV. Current tests used to detect CAV, such as invasive coronary angiography (ICA) and intravascular ultrasound (US) have clear limitations; in addition to being invasive with risk of complications, they are also expensive, time consuming, and require iodinated contrast, a concern in a population with high rates of kidney dysfunction. In addition, these tests may not be able to detect CAV in its early stages. Additionally, the diagnosis of CAV remains a challenge as angiography, the standard method for detecting focal plaques, lacks sensitivity in detecting CAV, and intravascular ultrasonography, a more sensitive method, lacks the ability to evaluate the entirety of the coronary arteries.
Key inclusion criteria (4 listed)
- ≥ 18 years of age at the time of enrollment
- Willing to provide written informed consent
- Completed cardiac PET within the last 2 weeks
- No changes to medication or intervention since the PET was completed
Key exclusion criteria (7 listed)
- Patients unable to fit into device
- Patients unable to lie supine for 5 minutes
- Patients with implanted ferromagnetic objects above the costal margin of the rib cage (implanted pacemakers, cardioverter/defibrillators, infusion pumps, and/or neuro stimulators).
- NOTE: Sternotomy wires stents are acceptable
- Implanted pacemakers or cardioverter/defibrillators
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 |
|---|---|---|
| CardioFluxCardioFlux MCG is a process that observes incremental changes in the heart's electrical activity by the magnetic fields generated by these currents. These magnetic fields have been used for decades via electrocardiogram to help diagnose and treat both acute and chronic cardiac pathology. The CardioFlux device reaches the potential of this phenomenon by sensing a complete magnetic field map. It is equipped with a magnetic shielding chamber and can attenuate magnetic field noise by a factor of nearly 1500 which maximizes signal to noise ratio. CardioFlux is an easy to operate, noninvasive modality that can detect the presence of ischemic cardiac tissue in symptomatic patients in a less than 5-minute scan. The device uses the proprietary software called Faraday which processes MCG scans, create diagnostic functional images, and run analytics. | Device | PET CAV 0, PET CAV 1, PET CAV 2/3 |
Primary outcome
To compare the performance (diagnostic capabilities) of magnetocardiography in the diagnosis of coronary vasculopathy (CAV) as compared to PET as the currently accepted gold standard non-invasive tool.
Time frame: 6 months
Ability of MCG to identify CAV 0 in heart transplant patients as measured by sensitivity, specificity, positive predictive value, and negative predictive value.
1 secondary outcome
To determine whether MCG is able to differentiate between CAV 0, 1, and 2/3, and to correlate with absolute stress myocardial blood flow, global CFR (Coronary flow reserve), and LVEF (Left ventricular ejection fraction), as measured by cardiac PET
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2023.
- Individual participant dataSharing planned: No
Related trials for Coronary Allograft Vasculopathy (CAV)
Recruiting
MARINER Trial: Multiparametric Cardiac PET for CAV Surveillance After Heart Transplantation
Cardiac Allograft Vasculopathy
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.
Paul Cremer, MD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Allograft Vasculopathy (CAV), run by Genetesis Inc. at 1 site in United States.
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 7 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: status not confirmed, as of the sponsor's last update on 11 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melanie L Gruen, MS (8594684273, melanie.gruen@genetesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To compare the performance (diagnostic capabilities) of magnetocardiography in the diagnosis of coronary vasculopathy (CAV) as compared to PET as the currently accepted gold standard non-invasive tool. (time frame: 6 months). 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 11 Jul 2023.