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IschemiaWACE-MCGNCT04739280

Women's Assessed Cardiovascular Evaluation With MCG

An observational study of Ischemia and Cardiac Disease, run by Genetesis Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Cardiovascular disease (CVD) is the number one cause of death for women over the age of 25, accounting for 1 of every 3 female deaths. Research has shown that while hypertension in women is less controlled, they are also less likely to be identified with ischemic heart disease and when diagnosed treated less… Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
What is being tested?
CardioFlux Magnetocardiography
Type of treatment
Medical device
How many people
32 participants
Where
1 siteUnited States
Study dates
15 Oct 2020to 21 Jul 2022
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
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: The following describes the targeted population population ≥ 18 years of age at the time of enrollment. Female Patients deemed at risk for cardiovascular disease (breast cancer survivors, patients referred to cardiologists, prior COVID-19 patients, etc.)

Who may be able to join

  • ≥ 18 years of age at the time of enrollment. Female Patients deemed at risk for cardiovascular disease (breast cancer survivors, patients referred to cardiologists, prior COVID-19 patients, etc.)

Who cannot join

  • < 18 years of age Patients unable to fit into device Non-ambulatory patients Positive response on CardioFlux Pre-Screening Form Patients with claustrophobia or unable to lie supine for 5 minutes Pregnant women Poor candidate for follow-up (e.g. no access to phone) Prisoners

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Genetesis Facility

    Mason, Ohio, 45040

Other trials in United States

About this study

Cardiovascular disease (CVD) is the number one cause of death for women over the age of 25, accounting for 1 of every 3 female deaths. Research has shown that while hypertension in women is less controlled, they are also less likely to be identified with ischemic heart disease and when diagnosed treated less aggressively than men. Moreover, women who are diagnosed with breast cancer have an increased risk for cardiovascular disease. The Women's Assessed Cardiovascular Evaluation with MCG (WACE-MCG) study is designed to collect CardioFlux scans on a select group of female volunteers who are Ms. Medicine patients. CardioFlux is used as a noninvasive MCG tool that analyzes and records the magnetic fields of the heart to detect various forms of heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 200 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 Magnetocardiography
Keywords
Cardiovascular Disease, Magnetic Field Map, CardioFLux, Ischemia, Magnetocardiography, MCG
Medical subject headings
Ischemia, Heart Diseases, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioFlux MagnetocardiographyDevice

    Magnetocardiography

Study groups in NCT04739280
Study groupRoleWhat they receive
Single center registry for WACEWe propose a single center registry for patients requiring diagnostic, screening, or surveillance for potential or existing cardiac illness. All eligible patients will undergo an MCG with periodic follow-ups. No treatment decisions will be based on the MCG findings, until CardioFlux has appropriate FDA labelling for clinical use.
Receives: Device: CardioFlux Magnetocardiography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Accuracy Statistics

    analyzing the accuracy of CardioFlux

    Measured: 6 Months

  2. Specificity Statistics

    analyzing the specificity of CardioFlux

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start15 Oct 2020
  3. Primary completion21 Jul 2022
  4. Study completion21 Jul 2022

Resources

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
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739280
Sponsor's protocol ID
1000-1
Acronym
WACE-MCG
Status last verified
Feb 2023
First submitted
27 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

  • Duda-Pyszny D, Trzeciak P, Gasior M. Coronary artery disease in women. Kardiochir Torakochirurgia Pol. 2018 Mar;15(1):44-48. doi: 10.5114/kitp.2018.74675. Epub 2018 Mar 28.

    PubMed 29681961

  • Garcia M, Mulvagh SL, Merz CN, Buring JE, Manson JE. Cardiovascular Disease in Women: Clinical Perspectives. Circ Res. 2016 Apr 15;118(8):1273-93. doi: 10.1161/CIRCRESAHA.116.307547.

    PubMed 27081110

  • Merz CN, Kelsey SF, Pepine CJ, Reichek N, Reis SE, Rogers WJ, Sharaf BL, Sopko G. The Women's Ischemia Syndrome Evaluation (WISE) study: protocol design, methodology and feasibility report. J Am Coll Cardiol. 1999 May;33(6):1453-61. doi: 10.1016/s0735-1097(99)00082-0.

    PubMed 10334408

  • Baldassarre LA, Raman SV, Min JK, Mieres JH, Gulati M, Wenger NK, Marwick TH, Bucciarelli-Ducci C, Bairey Merz CN, Itchhaporia D, Ferdinand KC, Pepine CJ, Walsh MN, Narula J, Shaw LJ; American College of Cardiology's Cardiovascular Disease in Women Committee. Noninvasive Imaging to Evaluate Women With Stable Ischemic Heart Disease. JACC Cardiovasc Imaging. 2016 Apr;9(4):421-35. doi: 10.1016/j.jcmg.2016.01.004.

    PubMed 27056162

  • Barish R, Lynce F, Unger K, Barac A. Management of Cardiovascular Disease in Women With Breast Cancer. Circulation. 2019 Feb 19;139(8):1110-1120. doi: 10.1161/CIRCULATIONAHA.118.039371.

    PubMed 30779651

  • 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 24667125

  • Goernig 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 19015988

  • Hailer 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 15660796

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemia and Cardiac Disease, 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 1 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 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?

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?

Accuracy Statistics (time frame: 6 Months). The study lists 2 primary outcomes in all. 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 NCT04739280, which also lists 8 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.

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