Coronary Microvascular DysfunctionMICRONCT05150054
MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction
An observational study of Coronary Microvascular Dysfunction and Ischemic Non-Obstructive Coronary Artery Disease, run by Genetesis Inc. at 4 sites in United States.
Trial summary
According to the Women's Ischemic Syndrome Evaluation database, there are approximately 3 to 4 million women and men who present with signs and symptoms that are suggestive of myocardial ischemia, however they have no obstructive coronary artery disease (INOCA). Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronary Microvascular Dysfunction, Ischemic Non-Obstructive Coronary Artery Disease
- What is being tested?
- CardioFlux
- Type of treatment
- Medical device
- How many people
- 93 participants
- Where
- 4 sitesUnited States
- Study dates
- 14 Jan 2022to 30 Jul 2023
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients presenting with signs and symptoms of chest pain that prompted further evaluation by either a heart angiogram or a scan of the heart (coronary CT angiogram) within the previous 5 years.
Who may be able to join
- ≥ 18 years of age at the time of enrollment
- Signs and symptoms of chest pain that prompted further evaluation by either a heart angiogram or a scan of the heart (coronary CT angiogram) within the previous 5 years
- Willing to provide written informed consent
- Non-obstructive CAD defined as 0 to 49% diameter reduction of a major epicardial vessel or a FFR>0.80
- Scheduled for CRT
- No cardiac medications in the last 24 hours of an MCG-CF scan (with the exception of the patients enrolled in the data development set)
Who cannot join
- Patients unable to fit into device
- Non-ambulatory patients
- Patients who meet device contraindications
- Patients unable to lie supine for 5 minutes
- History of noncompliance (with medical therapy, protocol, or follow-up)
- History of non-ischemic dilated or hypertrophic cardiomyopathy
Show all 16Show fewer
- Documented acute coronary syndrome (ACS) within previous 30 days
- Left ventricular ejection fraction (LVEF) <40%, New York Heart Association heart failure (NYHA HF) class III-IV, or hospitalization for Reduced ejection fraction (HFrEF) within 180 days
- Stroke within previous 180 days or intracranial hemorrhage at any time
- End-stage renal disease, on dialysis, or estimated glomerular filtration rate (eGFR) <30 ml/min.
- Severe valvular disease or likely to require surgery/Transcatheter aortic valve replacement (TVAR) within 3 years
- Life expectancy <3-yrs. due to non-cardiovascular comorbidity
- Enrolled in a competing clinical trial
- Prior intolerance to both an ACE-I and ARB
- If intolerant to a statin unless taking a PCSK9 as a statin replacement by their clinical provider
- Pregnancy
Trial locations and contacts
4 sites in 1 country.
United States4 sites
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic
Cleveland, Ohio, 44195
Ascension St. John
Detroit, Michigan, 48236
Genetesis Facility
Mason, Ohio, 45040
About this study
Official title: Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction
According to the Women's Ischemic Syndrome Evaluation database, there are approximately 3 to 4 million women and men who present with signs and symptoms that are suggestive of myocardial ischemia, however they have no obstructive coronary artery disease (INOCA). INOCA is defined as patients presenting with signs or symptoms of ischemia but no obstructive artery disease. Women are more likely than men to die from cardiovascular disease and more likely to present with no obstructive coronary artery disease. Patients who present with signs and symptoms suggestive of INOCA/MINOCA are also presenting with Coronary Microvascular Dysfunction (CMD). Coronary Microvascular Dysfunction is a dysfunction in the epicardial and/or microvascular endothelial and/or nonendothelial that limits myocardial perfusion. Today, there is no routinely offered/available noninvasive test that is used for the diagnosis of CMD, significantly hindering the ability to identify the disease in the standard of care. Magenetocardiography (MCG) has the opportunity to use its noninvasive imaging techniques to provide early management of CMD. 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 yield surface electric field potentials as measured by the electrocardiogram. Since MCG is a functional assessor of repolarization heterogeneity, it is hypothesized that MCG may be a useful frontline diagnostic 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 this population, with the goal of providing early and noninvasive insights for management of CMD. There will be a 12-month duration of the study where the investigators propose to collect MCG scans from approximately 150 patients who present to the Genetesis facility for a 15-minute CardioFlux scan appointment.
- Being tested
- CardioFlux
- Keywords
- INOCA, Magnetocardiography, CardioFlux, MCG, Coronary Microvascular Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioFluxDevice
Not an intervention
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CardioFlux
Analyzing the diagnostic accuracy of CardioFlux in determining the presence of coronary microvascular dysfunction
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 posted8 Dec 2021
- Study start14 Jan 2022
- Primary completion18 Jul 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Microvascular DysfunctionStudies 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
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genetesis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05150054
- Sponsor's protocol ID
- 1000-6
- Acronym
- MICRO
- Status last verified
- Aug 2023
- First submitted
- 18 Nov 2021
- Last updated
- 31 Aug 2023
- 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 31 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction
- ClinicalTrials.gov ID
- NCT05150054
- Acronym / sponsor ID
- MICRO / 1000-6
- Keywords
- INOCA, Magnetocardiography, CardioFlux, MCG, Coronary Microvascular Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Genetesis Inc.Industry (pharma, biotech, devices)
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 18 Jul 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 8 Dec 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.
According to the Women's Ischemic Syndrome Evaluation database, there are approximately 3 to 4 million women and men who present with signs and symptoms that are suggestive of myocardial ischemia, however they have no obstructive coronary artery disease (INOCA). INOCA is defined as patients presenting with signs or symptoms of ischemia but no obstructive artery disease. Women are more likely than men to die from cardiovascular disease and more likely to present with no obstructive coronary artery disease. Patients who present with signs and symptoms suggestive of INOCA/MINOCA are also presenting with Coronary Microvascular Dysfunction (CMD). Coronary Microvascular Dysfunction is a dysfunction in the epicardial and/or microvascular endothelial and/or nonendothelial that limits myocardial perfusion. Today, there is no routinely offered/available noninvasive test that is used for the diagnosis of CMD, significantly hindering the ability to identify the disease in the standard of care. Magenetocardiography (MCG) has the opportunity to use its noninvasive imaging techniques to provide early management of CMD. 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 yield surface electric field potentials as measured by the electrocardiogram. Since MCG is a functional assessor of repolarization heterogeneity, it is hypothesized that MCG may be a useful frontline diagnostic 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 this population, with the goal of providing early and noninvasive insights for management of CMD. There will be a 12-month duration of the study where the investigators propose to collect MCG scans from approximately 150 patients who present to the Genetesis facility for a 15-minute CardioFlux scan appointment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting with signs and symptoms of chest pain that prompted further evaluation by either a heart angiogram or a scan of the heart (coronary CT angiogram) within the previous 5 years.
Key inclusion criteria (6 listed)
- ≥ 18 years of age at the time of enrollment
- Signs and symptoms of chest pain that prompted further evaluation by either a heart angiogram or a scan of the heart (coronary CT angiogram) within the previous 5 years
- Willing to provide written informed consent
- Non-obstructive CAD defined as 0 to 49% diameter reduction of a major epicardial vessel or a FFR>0.80
- Scheduled for CRT
Key exclusion criteria (16 listed)
- Patients unable to fit into device
- Non-ambulatory patients
- Patients who meet device contraindications
- Patients unable to lie supine for 5 minutes
- History of noncompliance (with medical therapy, protocol, or follow-up)
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 |
|---|---|---|
| CardioFluxNot an intervention | Device | – |
Primary outcome
Diagnostic accuracy of CardioFlux
Time frame: 12 months
Analyzing the diagnostic accuracy of CardioFlux in determining the presence of coronary microvascular dysfunction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Coronary Microvascular Dysfunction
Active, not recruiting
A Single Center Diagnostic, Cross-sectional Study of Coronary Microvascular Dysfunction
Coronary Microvascular Disease, Ischemic Heart Disease
Active, not recruitingObservational study
The Role of CD34+ Stem Cells in the Pathogenesis of Takotsubo Syndrome
Tako Tsubo Cardiomyopathy, Microvascular Dysfunction
Recruiting
Invasive Evaluation and Phenotype-Guided Treatment of ANOCA in Women
ANOCA - Angina With Non-obstructive Coronary Arteries, Coronary Microvascular Dysfunction (CMD)
RecruitingObservational study
Mechanical Dyssynchrony and Microvascular Dysfunction by SPECT
Myocardial Blood Flow Reserve, Mechanical Dyssynchrony
Recruiting
Mental Stress Reactivity in Women With CMD
Post-menopause
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.
4 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 Microvascular Dysfunction and Ischemic Non-Obstructive Coronary Artery Disease, run by Genetesis Inc. at 4 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 31 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Diagnostic accuracy of CardioFlux (time frame: 12 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 31 Aug 2023.