An observational study in Ischemic Heart Disease, Coronary Microvascular Disease and Angina, sponsored by Genetesis Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-31.
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 57th largest by enrollment of the 67 observational ones that give a count, is one of 7 that started in 2023, is one of 67 observational ones, and was the 201st 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. 7 started in 2023.
This study's enrollment of 48 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.
This study will be an observational registry to investigate the ability of magnetocardiography (MCG) in determining the presence of myocardial ischemia with the absence of obstructive coronary artery disease, by using an invasive reference standard coronary flow reserve (CFR) measured using thermodilution for diagnosis. The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with cloud processing software. A CardioFlux scan appointment shall last approximately 15 minutes in duration and include a patient questionnaire following the scan.
This observational registry study focuses on investigating the efficacy of magnetocardiography (MCG) in detecting myocardial ischemia secondary to coronary microvascular dysfunction (CMD) in the absence of obstructive coronary artery disease. The reference standard for diagnosis will be invasive coronary flow reserve (CFR) measured using thermodilution.
The study utilizes a magnetocardiography (MCG) scanner known as CardioFlux, complemented by cloud processing software. The scanning procedure is designed to last approximately 15 minutes per participant, encompassing 5 minutes for patient preparation, 5 minutes for the CardioFlux scan, and an additional 5 minutes for a post-scan patient survey.
The primary objective is to assess the ability of MCG, through CardioFlux, to accurately determine the presence of myocardial ischemia in comparison to the reference standard CFR. The study will provide valuable insights into the diagnostic potential of MCG and its role in CMD detection, contributing to advancements in non-invasive cardiovascular diagnostics.
The primary study outcome measures shall be the detection of myocardial ischemia with no obstructive coronary artery disease (INOCA) using MCG-CF compared to Cardiac Thermodilution derived CFR. The secondary study outcome measures shall be the MCG Questionnaire, Demographic data (age, sex, height, weight, etc.), Relevant patient medical history, EKG results (if available), and Invasive CFR/angiogram results.
Men and women with suspected or confirmed myocardial ischemia with no obstructive coronary artery disease (INOCA).
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.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
Participants in this group exhibit no signs of Coronary Microvascular Disease (CMD), as evidenced by a CFR measurement equal to or greater than 2.5. This group serves as the comparative reference, representing individuals without CMD-related myocardial ischemia.
Device: CardioFlux Magnetocardiography
This group comprises participants demonstrating signs of Coronary Microvascular Disease (CMD), defined by a coronary flow reserve (CFR) measurement of less than 2.5. Participants in this category are experiencing myocardial ischemia without significant blockages in their coronary arteries.
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)
Detection of Myocardial Ischemia in the Absence of Obstructive Coronary Artery Disease (INOCA)
This observational registry study focuses on investigating the efficacy of magnetocardiography (MCG) in detecting myocardial ischemia secondary to coronary microvascular dysfunction (CMD) in the absence of obstructive coronary artery disease.
Time frame: 6 months
Patient-Reported Experiences with MCG
Time frame: 6 months
Participant Demographic Characteristics
weight (kg)
Time frame: 6 months
Participant Demographic Characteristics
age, sex, vital signs
Time frame: 6 months
Electrocardiogram (EKG)
If participants have undergone electrocardiogram (EKG) testing, the results will be considered to provide additional insights into their cardiac electrical activity.
Time frame: 6 months
Invasive Coronary Flow Reserve (CFR) and Angiogram Outcomes
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Ran from Dec 2023 to primary completion in May 2024, 4 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 4 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 May 2024. You cannot join it, but the record below documents what was studied.
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Genetesis Inc.