Coronary; IschemicMagneto-PETNCT05868902
A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
An observational study of Coronary; Ischemic, run by Genetesis Inc. at 2 sites in United States.
Trial summary
A multicenter observational data development registry collecting diagnostic measures via standard of care (SOC) cardiac PET in order gain a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary; Ischemic
- What is being tested?
- CardioFlux Magnetocardiography
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Aug 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women age 40 and up with suspected or confirmed coronary ischemia who are scheduled to undergo diagnostic cardiac PET, for non-emergent diagnostic purposes at an enrolling clinical trial center.
Who may be able to join
- Willing to provide informed consent
- Male or female, aged 40 and up (inclusive) at the time of enrollment
- Clinical suspicion of myocardial ischemia that clinician desired cardiac PET
- Completed cardiac PET within 2 weeks prior to study enrollment
Who cannot join
- Patients unable to fit into CardioFlux 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
- Ongoing atrial fibrillation or atrial flutter
- Life expectancy <1 yrs. due to non-cardiovascular comorbidity
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Robert Takla, MD contact
United States2 sites, 2 recruiting
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
Cynthia Rosser, (216) 444-4372, rosserc@ccf.org
Wael Jaber, MD
- Recruiting
Kettering Health
Kettering, Ohio, 45429
Allison Dymacek, allison.dymacek@ketteringhealth.org
Damien Valencia, MD
About this study
A multicenter observational data development registry collecting diagnostic measures via standard of care (SOC) cardiac PET in order gain a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia.
- Conditions
- Coronary; Ischemic
- Being tested
- CardioFlux Magnetocardiography
- Keywords
- Magnetocardiography, Coronary Ischemia
- Medical subject headings
- Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioFlux MagnetocardiographyDevice
The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)
| Study group | Role | What they receive |
|---|---|---|
| Negative Cardiac PET | Participants without clinical significant findings for coronary ischemia on cardiac PET scan. Receives: Device: CardioFlux Magnetocardiography | |
| Positive Cardiac PET | Participants with findings indicative of coronary ischemia on cardiac PET scan. Receives: Device: CardioFlux Magnetocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To collect diagnostic data using SOC diagnostic cardiac PET testing for the purposes of gaining a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2023
- Study start28 Aug 2023
- Primary completion1 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary; IschemicStudies 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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genetesis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05868902
- Sponsor's protocol ID
- 1000-8
- Acronym
- Magneto-PET
- Status last verified
- Feb 2025
- First submitted
- 11 May 2023
- Last updated
- 20 Feb 2025
- 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 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Registry of Cardiac PET and CardioFlux Magnetocardiography in Patients With Suspected Coronary Ischemia.
- ClinicalTrials.gov ID
- NCT05868902
- Acronym / sponsor ID
- Magneto-PET / 1000-8
- Conditions
- Coronary; Ischemic
- Keywords
- Magnetocardiography, Coronary Ischemia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Genetesis Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2023 (actual)
- Primary completion
- 1 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 22 May 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.
A multicenter observational data development registry collecting diagnostic measures via standard of care (SOC) cardiac PET in order gain a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Negative Cardiac PET | – | Device: CardioFlux MagnetocardiographyParticipants without clinical significant findings for coronary ischemia on cardiac PET scan. |
| Positive Cardiac PET | – | Device: CardioFlux MagnetocardiographyParticipants with findings indicative of coronary ischemia on cardiac PET scan. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women age 40 and up with suspected or confirmed coronary ischemia who are scheduled to undergo diagnostic cardiac PET, for non-emergent diagnostic purposes at an enrolling clinical trial center.
Key inclusion criteria (4 listed)
- Willing to provide informed consent
- Male or female, aged 40 and up (inclusive) at the time of enrollment
- Clinical suspicion of myocardial ischemia that clinician desired cardiac PET
- Completed cardiac PET within 2 weeks prior to study enrollment
Key exclusion criteria (5 listed)
- Patients unable to fit into CardioFlux 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
- Ongoing atrial fibrillation or atrial flutter
- Life expectancy <1 yrs. due to non-cardiovascular comorbidity
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 |
|---|---|---|
| CardioFlux MagnetocardiographyThe device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online) | Device | Negative Cardiac PET, Positive Cardiac PET |
Primary outcome
To collect diagnostic data using SOC diagnostic cardiac PET testing for the purposes of gaining a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: No
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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.
Robert Takla, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary; Ischemic, run by Genetesis Inc. at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 20 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zoe E Swann, PhD (4802868695, zoe.swann@genetesis.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect diagnostic data using SOC diagnostic cardiac PET testing for the purposes of gaining a better understanding of how CardioFlux MCG may be used in the detection of coronary ischemia (time frame: 24 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 20 Feb 2025.