An observational study in Ischemic Heart Disease, Coronary Microvascular Disease and Angina, sponsored by Genetesis Inc.. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-10.
Sponsored by Genetesis Inc. · Observational
Among 218 studies in Myocardial Ischemia with a site in United States — 23 open to participants now, 26 under way, none of them phase 3. Myocardial Ischemia · United States.
Among the 218 studies in Myocardial Ischemia with a site in United States, this one is the 41st largest by enrollment of the 67 observational ones that give a count, is one of 6 that started in 2024, is one of 67 observational ones, and was the 202nd registered.
1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.
Browse Myocardial Ischemia studies →23 of the 218 studies in Myocardial Ischemia with a site in United States are open now. Recruiting first, the newest first:
Bettina Mittendorfer · Sites in United States
Medtronic Cardiac Ablation Solutions · Sites in United States
Teleflex · Sites in United States, Latvia
The Cleveland Clinic · Sites in United States
Mayo Clinic · 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 135 Myocardial Ischemia studies recruiting now, 92 (68%) set no upper age limit and 6 (4%) stop at 75 or younger; 14 take children under 18; 20 take healthy volunteers.
This study: 18 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.
218 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 16 · Phase 2 31 · Phase 3 21 · Phase 4 19
First in 1990; this study’s year is marked. 6 started in 2024.
This study's enrollment of 136 is below the median of 318 across 398 observational studies indexed under Myocardial Ischemia.
Median enrollment 87 across the 150 interventional studies, 205 across the 67 observational. Of the 172 that completed or were terminated, 77 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
82 of 218 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 3 studies filed under Myocardial Ischemia — fewer than ten, so there is no comparison to draw.
6 of the studies in Myocardial Ischemia with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06703489Medtronic Cardiac Ablation SolutionsSafety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia (Sphere-9 VT EFS) | 2026-11 |
| NCT06271577AliveCorSmartphone Twelve-Lead ECG Utility In ST-Elevation Myocardial Infarction II | 2026-12 |
| NCT02855554Medical University of South CarolinaQuantitative Cardiac Parametric Mapping | 2026-12 |
| NCT05788666NYU Langone HealthUse of GeriKit to Better Phenotype Older Adults With Ischemic Heart Disease | 2027-03-01 |
| NCT06047028University of Texas Southwestern Medical CenterPrognostic Value of Hyperpolarized 13C MRI for Clinical Myocardial Viability | 2027-06-30 |
Among the 218 studies in Myocardial 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 prospective, multicenter, observational, single-arm trial to validate CardioFlux MCG's ability to diagnose myocardial ischemia caused by coronary microvascular dysfunction in patients with suspected ischemia and confirmed no obstructive coronary artery disease (suspected INOCA) by using diagnostic measures of coronary flow reserve (CFR) via invasive angiography as a reference standard for diagnosis.
Magnetocardiography (MCG) is a noninvasive imaging modality that has been extensively studied over the past several decades as a diagnostic imaging solution for various forms of cardiovascular disease. MCG measures the magnetic field that arises from the electrical activity of the heart's pacemaker activity, the very same activity which yields surface electric field potentials as measured by the electrocardiogram. Unlike electrocardiographic signals, however, MCG signals are undistorted by conductive tissue noise, and are highly sensitive to ischemic injury and vortex currents missed by the same electrocardiographic measurements. Accordingly, numerous clinical trials suggest the usefulness of MCG for the evaluation of ischemia in patients with suspected acute coronary syndrome.
There is a growing body of evidence demonstrating the usefulness of MCG in the detection of myocardial ischemia, both in patients with symptoms of ACS, and in patients with stable angina. Since MCG is a functional assessor of depolarization and repolarization heterogeneity, it is hypothesized that MCG may be a useful frontline diagnostic modality to identify CMD in patients who would otherwise have normal coronary CT angiograms and/or stress tests. The proposed study intends to study the diagnostic accuracy of MCG in patients with suspected INOCA.
This demonstrates a significant unmet clinical need in the assessment of patients, and especially women, with INOCA. The current standard of care for these patients is resource/time intensive and associated with a significant rate of non-diagnostic clinical data requiring expensive and invasive evaluation for safe patient management. Magnetocardiography offers the potential for rapid, safe, noninvasive, non-radiologic assessment of the INOCA population, and may lead to earlier treatment strategies for CMD patients.
From the participating clinical sites, patients age ≥18 years who presented with chest pain or exertional dyspnea concerning for myocardial ischemia with no obstructive epicardial CAD on invasive or computed tomographic coronary angiography will be screened and subsequently enrolled when meeting criteria. This is a prospective observational study used for clinical data collection for the clinical validation testing of the CardioFlux MCG system. There will be no intervention introduced by the study device. The interpretation of the CardioFlux MCG data made by the study reader(s) will not be known to the patient's treating physician. Similarly, the patient's coronary physiology data, diagnosis, or interventions made by the patient's treating physician in following the standard of care will not be known to any of the scan readers. Except for the introduction of the MCG scan, there will be no other alteration to the patient standard of care.
Men and women aged 18 years and older with chronic/stable angina and no obstructive coronary artery disease (suspected INOCA) with completed invasive CFR measurement within 180 days or are scheduled to undergo invasive angiography with CFR assessment by bolus thermodilution within 30 days of informed consent 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.
In order to be eligible to participate in this study, an individual must meet all the following criteria:
Invasive CFR (via bolus thermodilution) completed within 180 days, or scheduled within 30 days, of informed consent.
4.1. CFR must be performed in the mid Left Anterior Descending (LAD) vessel.
5.3.2. Implanted pacemakers or cardioverter/defibrillators. 5.3.3. Implanted infusion pumps and/or neuro stimulators. 5.3.4. Note: sternotomy wires and stents are acceptable. 5.3.5. Note: Failure to meet inclusion criteria 5.3 will render the MCG scan uninterpretable. However, any patient who may be scanned with the presence of any of the above objects is not at any risk of harm by the device. Prosthetic joints are allowed if the MCG Quality Preview is acceptable.
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation in this study:
Obstructive CAD (either anatomical or physiological) defined as:
1.1. ≥ 70% lesion in any major epicardial or branch vessel by CT or invasive Angiography; 1.2. ≥ 50% lesion in the Left Main (LM) vessel by CT or invasive Angiography; 1.3. or either an FFR\<0.80 or iFR or RFR \<0.89 in the obstructed vessel,
Any of the following cardiac pathologies:
2.1. Epicardial spasm. 2.2. History of non-ischemic dilated or hypertrophic cardiomyopathy. 2.3. Suspected myocarditis. 2.4. Documented acute coronary syndrome (ACS) within previous 30 days. 2.5. Known (LVEF) \<45% on most recent assessment (can be via ECHO), or hospitalization for Reduced ejection fraction within 180 days. (HFpEF is allowed).
2.6. Currently in atrial fibrillation or atrial flutter at the time of enrollment.
2.7. Complete Bundle Branch Block. 2.8. Known moderate or severe valvular disease (anything besides mild). 2.9. Known severe Left ventricular hypertrophy (LVH) as determined by Echocardiography.
2.10. Dextrocardia.
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 share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
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.
Patients who have confirmed presence of CMD via invasive angiography/CFR
Device: CardioFlux
Patients who have confirmed absence of CMD via invasive angiography/CFR
Device: CardioFlux
The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity.
Diagnostic accuracy of CardioFlux MCG in determining the presence of CMD
Diagnostic accuracy of CardioFlux MCG in determining the presence of coronary microvascular dysfunction, as measured by AUC with ground truth defined as an invasive CFR \<2.5 for bolus thermodilution method. H0: AUC\<0.55 Ha: AUC≥0.55
Time frame: 6 months
Sensitivity and specificity in determining presence of CMD (Rule In)
Patients who have confirmed presence of CMD via invasive CFR: Sensitivity and specificity of CardioFlux MCG in determining the presence of CMD with the gold standard defined as an invasive CFR \<2.5 for thermodilution method as determined by a positive MCG scan output as defined by a Magnetic Dispersion Dynamics (MDD) score less than 41 fT/ms. Sensitivity * H0\<0.30 * Ha≥0.30 Specificity * H0\<0.70 * Ha ≥0.70
Time frame: 6 months
Sensitivity and specificity in determining presence of CMD (Rule Out)
Patients who have confirmed absence of CMD via invasive CFR: Sensitivity * H0\<0.70 * Ha≥0.70 Specificity * H0\<0.30 * Ha ≥0.30
Time frame: 6 months
ROC/AUC, sensitivity and specificity at CFR cut-offs of <2.0 and 3.0.
ROC/AUC, sensitivity and specificity for invasive CFR by thermodilution methods at CFR cut-offs of \<2.0 and 3.0.
Time frame: 6 months
Patient-Reported Experiences with CardioFlux
Self-reported questionnaire (5 questions scored 1 (very dissatisfied) to 5 (very satisfied) with a minimum score of 5 and a maximum score of 25.
Time frame: 6 months
Participant Age
Age (years)
Time frame: 6 months
Participant Height
in meters; if known
Time frame: 6 months
Participant Weight
in kilograms; if known
Time frame: 6 months
Participant Gender at Birth
Male/Female
Time frame: 6 months
Index of Microvascular Resistance (IMR)
Sensitivity, Specificity, and ROC/AUC for CardioFlux will also be calculated against Index of Microvascular Resistance (IMR), defined as \>25.
Time frame: 6 months
Comparison of bolus vs. continuous thermodilution
Comparison of bolus thermodilution (CFR-bolus) and continuous thermodilution (CFR-cont) against MCG when CFR-cont is available.
Time frame: 6 months
Number of Adverse Events
Safety will be monitored by the reporting of adverse events (related and non-related to the device) throughout the trial.
Time frame: 6 months
Seattle Angina Questionnaire - 7
For patients whose CFR was completed within 30 days of MCG scan, SAQ-7 scores may be measured and analyzed.
Time frame: 30 days
Comparison of functional vs structural CMD
Comparison of functional vs structural CMD will be analyzed (endothelial dependent vs independent).
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2024 to primary completion in Apr 2025, 10 months.
Of 39 industry-sponsored observational studies under Myocardial Ischemia, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 40. This study's 10 months is below that.
Counting every sponsor, half of 204 studies reached it within 40 months; a quarter within 21 and three quarters within 90.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Genetesis Inc.