An observational study in Coronary; Ischemic, sponsored by Genetesis Inc.. Recruiting at 2 sites in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2025-02-20.
Sponsored by Genetesis Inc. · Observational
Among 155 studies in Ischemia with a site in United States — 20 open to participants now, 24 under way, 1 of them phase 3. Ischemia · United States.
Among the 155 studies in Ischemia with a site in United States, this one is the 16th largest by planned enrollment of the 53 observational ones that give a count, is one of 2 that started in 2023, is one of 53 observational ones, reaches primary completion later than 2 of the 23 other live ones, and was the 145th registered.
545 studies on the registry are indexed under Ischemia; 72 are open to participants now.
Browse Ischemia studies →20 of the 155 studies in Ischemia with a site in United States are open now. Recruiting first, the newest first:
Medical University of South Carolina · Sites in United States
Baylor Research Institute · Sites in United States
Penumbra Inc. · Sites in United States, Australia, Brazil and 4 more countries
Samaritan Biologics · Sites in United States
NYU Langone Health · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 45 Ischemia studies recruiting now, 35 (78%) set no upper age limit and 5 (11%) stop at 75 or younger; 4 take children under 18; 7 take healthy volunteers.
This study: 40 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
155 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 36 · Phase 3 13 · Phase 4 7
First in 1993; this study’s year is marked. 2 started in 2023.
This study's planned enrollment of 300 is above the median of 176 across 166 observational studies indexed under Ischemia.
Median enrollment 60 across the 100 interventional studies, 191 across the 53 observational. Of the 109 that completed or were terminated, 38 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
60 of 155 have an industry lead sponsor. The 10 most frequent:
Genetesis Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Genetesis Inc. has 6 studies filed under Ischemia — fewer than ten, so there is no comparison to draw.
10 of the studies in Ischemia with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05065216Phase 3DiaMedica Therapeutics IncTreatment of Acute Ischemic Stroke (ReMEDy2 Trial) | 2026-12 |
| NCT06271577AliveCorSmartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II | 2026-12 |
| NCT06437028Samaritan BiologicsEvaluating the Efficacy of Perinatal Membrane Allografts in Addition to the Standard of Care for the Treatment of Non-healing Diabetic Foot Ulcers. | 2027-03 |
| NCT00762333UConn HealthCirculating Markers for Ischemic Heart Disease | 2027-03 |
| NCT06896903Baylor Research InstituteAnalysis of Coronary Reactivity Testing With and Without Intracoronary Nitrate Testing | 2027-05-01 |
Among the 155 studies in Ischemia with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants without clinical significant findings for coronary ischemia on cardiac PET scan.
Device: CardioFlux Magnetocardiography
Participants with findings indicative of coronary ischemia on cardiac PET scan.
Device: CardioFlux Magnetocardiography
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)
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
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2023 (actual). Primary completion is estimated for Jun 2025, 21 months after the start.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Genetesis Inc.