Acute Myocardial InfarctionGEARNCT05051228
Genetesis Accelerated Registry
An observational study of Acute Myocardial Infarction and Acute Coronary Syndrome, run by Genetesis Inc. at 1 site in United States.
Trial summary
Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Myocardial Infarction, Acute Coronary Syndrome
- What is being tested?
- CardioFlux
- Type of treatment
- Medical device
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2021to Jul 2024
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: All volunteers presenting to the Genetesis facility (5950 Mason Montgomery Rd, Suite 1400, Mason, OH 45040) meeting the inclusion criteria for performance of a magnetocardiograph scan for diagnosis, risk assessment, or treatment monitoring due to cardiac illness (as determined by the Investigators) may participate. All other exclusion criteria are not specified contraindications for the device. If a patient has metal implants or implanted devices in your torso (e.g., pacemaker) or large amounts of implanted metal in other parts of their body, these may make their scan unreadable. There are no risks to the patient if they enter CardioFlux with metal. This scenario would simply require a re-scan, if the metal can be removed, or an unusable scan.
Who may be able to join
- 1. ≥ 18 years of age at the time of enrollment.
Who cannot join
- < 18 years of age
- Patients unable to fit into device
- Non-ambulatory patients
- Patients with present with or have reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium
- Patients with claustrophobia or unable to lie supine for 5 minutes
- Pregnant women
Show all 9Show fewer
- Poor candidate for follow-up (e.g. no access to phone)
- Prisoners
- Patients with a language barrier/language difficulties
Trial locations and contacts
1 site in 1 country.
About this study
Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The purpose of the Genetesis Accelerated Registry (GEAR) study is to understand the potential for magnetocardiography to be utilized as a diagnostic, screening or surveillance tool for heart disease in healthy and non-healthy volunteers. Magnetocardiography (MCG) is a diagnostic method that analyzes and records the magnetic fields of the heart for the detection of various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 500 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.
- Being tested
- CardioFlux
- Keywords
- ischemia, acute myocardial injuries, CardioFlux, MCG, Cardiovascular disease
- Medical subject headings
- Acute Coronary Syndrome, Ischemia, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioFluxDevice
Magnetocardiography (MCG) is a noninvasive method that measure the magnetic field that arises from the electrical activity of the heart cycle.
| Study group | Role | What they receive |
|---|---|---|
| GEAR cohort | This is a noninvasive study that screens healthy and non-healthy volunteers for cardiovascular disease. Receives: Device: CardioFlux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of Cardioflux diagnosis/screening of ACS
Comparing the accuracy of Cardioflux to current standard of care when diagnosing/screening for ACS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start27 Jan 2021
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Why it stopped: Resourcing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies 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
- 500 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
- NCT05051228
- Sponsor's protocol ID
- 1000-05
- Acronym
- GEAR
- Status last verified
- Feb 2023
- First submitted
- 28 Jan 2021
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chaikovsky I, Hailer B, Sosnytskyy V, Lutay M, Mjasnikov G, Kazmirchuk A, Bydnyk M, Lomakovskyy A, Sosnytskaja T. Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study. Coron Artery Dis. 2014 Sep;25(6):474-84. doi: 10.1097/MCA.0000000000000107.
PubMed 24667125Hailer B, Chaikovsky I, Auth-Eisernitz S, Schafer H, Van Leeuwen P. The value of magnetocardiography in patients with and without relevant stenoses of the coronary arteries using an unshielded system. Pacing Clin Electrophysiol. 2005 Jan;28(1):8-16. doi: 10.1111/j.1540-8159.2005.09318.x.
PubMed 15660796Goernig M, Liehr M, Tute C, Schlosser M, Haueisen J, Figulla HR, Leder U. Magnetocardiography based spatiotemporal correlation analysis is superior to conventional ECG analysis for identifying myocardial injury. Ann Biomed Eng. 2009 Jan;37(1):107-11. doi: 10.1007/s10439-008-9598-5. Epub 2008 Nov 18.
PubMed 19015988Kwong JS, Leithauser B, Park JW, Yu CM. Diagnostic value of magnetocardiography in coronary artery disease and cardiac arrhythmias: a review of clinical data. Int J Cardiol. 2013 Sep 1;167(5):1835-42. doi: 10.1016/j.ijcard.2012.12.056. Epub 2013 Jan 19.
PubMed 23336954
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetesis Accelerated Registry
- ClinicalTrials.gov ID
- NCT05051228
- Acronym / sponsor ID
- GEAR / 1000-05
- Keywords
- ischemia, acute myocardial injuries, CardioFlux, MCG, Cardiovascular disease
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Resourcing
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Genetesis Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jan 2021 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 21 Sep 2021 (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.
Heart disease is the number one cause of death in the United States, with over 650,000 deaths in 2019 alone. Many healthy individuals possess key risk factors for heart disease which include but are not limited to high blood pressure, high cholesterol, family history of heart disease, and diabetes. The purpose of the Genetesis Accelerated Registry (GEAR) study is to understand the potential for magnetocardiography to be utilized as a diagnostic, screening or surveillance tool for heart disease in healthy and non-healthy volunteers. Magnetocardiography (MCG) is a diagnostic method that analyzes and records the magnetic fields of the heart for the detection of various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 500 volunteers who present to the Genetesis facility for a 5-minute CardioFlux MCG scan. The volunteers will be contacted at intervals over a 1-year period for follow-up data and may choose whether or not they would like to provide follow-up data or participate in another scan.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GEAR cohort | – | Device: CardioFluxThis is a noninvasive study that screens healthy and non-healthy volunteers for cardiovascular disease. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All volunteers presenting to the Genetesis facility (5950 Mason Montgomery Rd, Suite 1400, Mason, OH 45040) meeting the inclusion criteria for performance of a magnetocardiograph scan for diagnosis, risk assessment, or treatment monitoring due to cardiac illness (as determined by the Investigators) may participate. All other exclusion criteria are not specified contraindications for the device. If a patient has metal implants or implanted devices in your torso (e.g., pacemaker) or large amounts of implanted metal in other parts of their body, these may make their scan unreadable. There are no risks to the patient if they enter CardioFlux with metal. This scenario would simply require a re-scan, if the metal can be removed, or an unusable scan.
Key inclusion criteria (1 listed)
- 1. ≥ 18 years of age at the time of enrollment.
Key exclusion criteria (9 listed)
- < 18 years of age
- Patients unable to fit into device
- Non-ambulatory patients
- Patients with present with or have reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium
- Patients with claustrophobia or unable to lie supine for 5 minutes
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 |
|---|---|---|
| CardioFluxMagnetocardiography (MCG) is a noninvasive method that measure the magnetic field that arises from the electrical activity of the heart cycle. | Device | GEAR cohort |
Primary outcome
Accuracy of Cardioflux diagnosis/screening of ACS
Time frame: 12 months
Comparing the accuracy of Cardioflux to current standard of care when diagnosing/screening for ACS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
- Background: PubMed 24667125Chaikovsky I, Hailer B, Sosnytskyy V, Lutay M, Mjasnikov G, Kazmirchuk A, Bydnyk M, Lomakovskyy A, Sosnytskaja T. Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study. Coron Artery Dis. 2014 Sep;25(6):474-84. doi: 10.1097/MCA.0000000000000107.
- Background: PubMed 15660796Hailer B, Chaikovsky I, Auth-Eisernitz S, Schafer H, Van Leeuwen P. The value of magnetocardiography in patients with and without relevant stenoses of the coronary arteries using an unshielded system. Pacing Clin Electrophysiol. 2005 Jan;28(1):8-16. doi: 10.1111/j.1540-8159.2005.09318.x.
- Background: PubMed 19015988Goernig M, Liehr M, Tute C, Schlosser M, Haueisen J, Figulla HR, Leder U. Magnetocardiography based spatiotemporal correlation analysis is superior to conventional ECG analysis for identifying myocardial injury. Ann Biomed Eng. 2009 Jan;37(1):107-11. doi: 10.1007/s10439-008-9598-5. Epub 2008 Nov 18.
- Background: PubMed 23336954Kwong JS, Leithauser B, Park JW, Yu CM. Diagnostic value of magnetocardiography in coronary artery disease and cardiac arrhythmias: a review of clinical data. Int J Cardiol. 2013 Sep 1;167(5):1835-42. doi: 10.1016/j.ijcard.2012.12.056. Epub 2013 Jan 19.
- Individual participant dataSharing planned: No
Related trials for Acute Myocardial Infarction
Enrolling by invitationPhase 3
Selatogrel Outcome Study in Suspected Acute Myocardial Infarction
Acute Myocardial Infarction
Recruiting
CRP Apheresis in Infarct-Related Cardiogenic Shock
Cardiogenic Shock, Acute Myocardial Infarction (AMI)
Recruiting
Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support
Cardiogenic Shock, Acute Myocardial Infarction of Inferior Wall
Recruiting
Ezetimibe Utilization Early After Acute Myocardial Infarction, "EzAMI Trial"
Acute Myocardial Infarction, Dyslipidemias
Not yet recruitingObservational study
iLITE, Clinical Performance of the Angiolite™ Drug-Eluting Stent
PCI Patients, de Novo Coronary Lesions
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Acute Myocardial Infarction and Acute Coronary Syndrome, 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 1 inclusion and 9 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: paused, as of the sponsor's last update on 23 Feb 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of Cardioflux diagnosis/screening of ACS (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05051228, which also lists 4 linked publications.
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 23 Feb 2023; AzTrials last refreshed its copy on 28 Oct 2026.