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Magnetocardiography Endocrine Registry (MACENDOR)

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ClinicalTrials.gov Identifier: NCT04739254
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : January 21, 2022
Sponsor:
Information provided by (Responsible Party):
Genetesis Inc.

Study Description
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Brief Summary:
Endocrine disorders like Type 2 diabetes mellitus (T2DM) represent complex cardiometabolic disease processes affecting approximately 462 million individuals worldwide and is associated with a two- to three-fold increase in cardiovascular mortality. Individuals with T2DM are at an increased risk of developing cardiovascular disease. Research has shown individuals with T2DM and no previous history of coronary artery disease are still at similar risk rates for cardiovascular events as patients with a prior myocardial infarction. The MAgenetoCardiography ENDOcrine Registry (MACENDOR) study is designed to collect CardioFlux scans on a select group of volunteers who are high-risk patients with endocrine disorders. CardioFlux is used as a noninvasive magnetocardiography (MCG) tool that analyzes and records the magnetic fields of the heart to screen volunteers for heart disease. There will be a 12-month duration of the study where we propose to collect screening data from approximately 250 volunteers who present to the Genetesis facility for a 5-minute CardioFlux 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.

Condition or disease Intervention/treatment
Endocrine Disorder Other: Not an intervention

Study Design
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Study Type : Observational
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetocardiography Endocrine Registry
Actual Study Start Date : December 14, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Other: Not an intervention
    Not an intervention

Outcome Measures
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Primary Outcome Measures :
  1. Accuracy statistics [ Time Frame: 12 months ]
    analyzing the accuracy of CardioFlux

  2. Specificity statistics [ Time Frame: 12 months ]
    analyzing the specificity of CardiFlux


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are at risk for cardiovascular disease due to endocrine disorders.
Criteria

Inclusion Criteria:

  1. ≥ 18 years of age at the time of enrollment
  2. Patients deemed at risk for cardiovascular disease from endocrine disorders

Exclusion Criteria:

  1. < 18 years of age
  2. Patients unable to fit into device
  3. Non-ambulatory patients
  4. Positive response(s) on CardioFlux Pre-Screening Form
  5. Patients with claustrophobia or unable to lie supine for five minutes
  6. Pregnant women
  7. Poor candidates for follow-up (e.g., no access to phone)
  8. Prisoners
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739254


Contacts
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Contact: Anthony Senagore, M.D. 513-715-5045 anthony@genetesis.com
Contact: Samantha Legreaux, M.S. 513-715-5045 sam.legreaux@genetesis.com

Locations
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United States, Ohio
Genetesis Facility Recruiting
Mason, Ohio, United States, 45040
Contact: Samantha Legreaux, M.S.         
Sponsors and Collaborators
Genetesis Inc.
Investigators
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Principal Investigator: Anthony Senagore, M.D. Genetesis Inc.
More Information
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Publications:
Emerging Risk Factors Collaboration, Di Angelantonio E, Kaptoge S, Wormser D, Willeit P, Butterworth AS, Bansal N, O'Keeffe LM, Gao P, Wood AM, Burgess S, Freitag DF, Pennells L, Peters SA, Hart CL, Håheim LL, Gillum RF, Nordestgaard BG, Psaty BM, Yeap BB, Knuiman MW, Nietert PJ, Kauhanen J, Salonen JT, Kuller LH, Simons LA, van der Schouw YT, Barrett-Connor E, Selmer R, Crespo CJ, Rodriguez B, Verschuren WM, Salomaa V, Svärdsudd K, van der Harst P, Björkelund C, Wilhelmsen L, Wallace RB, Brenner H, Amouyel P, Barr EL, Iso H, Onat A, Trevisan M, D'Agostino RB Sr, Cooper C, Kavousi M, Welin L, Roussel R, Hu FB, Sato S, Davidson KW, Howard BV, Leening MJ, Leening M, Rosengren A, Dörr M, Deeg DJ, Kiechl S, Stehouwer CD, Nissinen A, Giampaoli S, Donfrancesco C, Kromhout D, Price JF, Peters A, Meade TW, Casiglia E, Lawlor DA, Gallacher J, Nagel D, Franco OH, Assmann G, Dagenais GR, Jukema JW, Sundström J, Woodward M, Brunner EJ, Khaw KT, Wareham NJ, Whitsel EA, Njølstad I, Hedblad B, Wassertheil-Smoller S, Engström G, Rosamond WD, Selvin E, Sattar N, Thompson SG, Danesh J. Association of Cardiometabolic Multimorbidity With Mortality. JAMA. 2015 Jul 7;314(1):52-60. doi: 10.1001/jama.2015.7008. Erratum in: JAMA. 2015 Sep 15;314(11):1179. Leening, Maarten [corrected to Leening, Maarten J G].

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Responsible Party: Genetesis Inc.
ClinicalTrials.gov Identifier: NCT04739254    
Other Study ID Numbers: 1000-4
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: January 21, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Genetesis Inc.:
endocrine disorders
MCG
Cardiovascular disease
ischemia
CardioFlux
Additional relevant MeSH terms:
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Endocrine System Diseases