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SuspendedNCT04739254MACENDORUpdated Oct 12, 2023

Magnetocardiography Endocrine Registry

An observational study in Endocrine Disorder, sponsored by Genetesis Inc.. Suspended at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-10-12.

Sponsored by Genetesis Inc. · Observational

Why this study was suspended
Resourcing
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Endocrine Disorder

Keywords

  • endocrine disorders
  • MCG
  • Cardiovascular disease
  • ischemia
  • CardioFlux
03

In context

Endocrine System Diseases

322 studies on the registry are indexed under Endocrine System Diseases; 51 are open to participants now.

This study's planned enrollment of 250 is above the median of 134 across 88 observational studies indexed under Endocrine System Diseases.

Browse Endocrine System Diseases studies →

Lead sponsor

Genetesis Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients who are at risk for cardiovascular disease due to endocrine disorders.

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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Interventions

  • Diagnostic testCardioFlux

    Magnetocardiography

06

What researchers measure

Primary outcomes

  1. Accuracy statistics

    analyzing the accuracy of CardioFlux

    Time frame: 12 months

  2. Specificity statistics

    analyzing the specificity of CardiFlux

    Time frame: 12 months

07

Study locations

1 site
  • Genetesis Facility
    Mason, Ohio 45040, United States
08

References and documents

Publications

  • Ogurtsova K, da Rocha Fernandes JD, Huang Y, Linnenkamp U, Guariguata L, Cho NH, Cavan D, Shaw JE, Makaroff LE. IDF Diabetes Atlas: Global estimates for the prevalence of diabetes for 2015 and 2040. Diabetes Res Clin Pract. 2017 Jun;128:40-50. doi: 10.1016/j.diabres.2017.03.024. Epub 2017 Mar 31. PubMed 28437734 ↗
  • Rao Kondapally Seshasai S, Kaptoge S, Thompson A, Di Angelantonio E, Gao P, Sarwar N, Whincup PH, Mukamal KJ, Gillum RF, Holme I, Njolstad I, Fletcher A, Nilsson P, Lewington S, Collins R, Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862. Erratum In: N Engl J Med. 2011 Mar 31;364(13):1281. PubMed 21366474 ↗
  • 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, Haheim 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, Svardsudd K, van der Harst P, Bjorkelund 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, Dorr 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, Sundstrom J, Woodward M, Brunner EJ, Khaw KT, Wareham NJ, Whitsel EA, Njolstad I, Hedblad B, Wassertheil-Smoller S, Engstrom 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. doi: 10.1001/jama.2015.10410.. Leening, Maarten [corrected to Leening, Maarten J G]. PubMed 26151266 ↗
  • Tancredi M, Rosengren A, Svensson AM, Kosiborod M, Pivodic A, Gudbjornsdottir S, Wedel H, Clements M, Dahlqvist S, Lind M. Excess Mortality among Persons with Type 2 Diabetes. N Engl J Med. 2015 Oct 29;373(18):1720-32. doi: 10.1056/NEJMoa1504347. PubMed 26510021 ↗
  • Simmons RK, Griffin SJ, Lauritzen T, Sandbaek A. Effect of screening for type 2 diabetes on risk of cardiovascular disease and mortality: a controlled trial among 139,075 individuals diagnosed with diabetes in Denmark between 2001 and 2009. Diabetologia. 2017 Nov;60(11):2192-2199. doi: 10.1007/s00125-017-4299-y. Epub 2017 Aug 23. PubMed 28831539 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Dec 2020 to primary completion in May 2022, 16 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 27, 2021
First posted
Feb 4, 2021
StartActual
Dec 14, 2020
Primary completionActual
May 1, 2022
CompletionEst.
May 1, 2030
Last update
Oct 12, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04739254
Lead sponsor
Genetesis Inc.
Responsible party
Sponsor
First posted
Feb 4, 2021
Start date
Dec 14, 2020
Primary completion
May 1, 2022
Completion
May 1, 2030 (estimated)
Last update
Oct 12, 2023

Study contacts

Anthony Senagore, M.D.
principal investigator · Genetesis Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is suspended, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Genetesis Inc.

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