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NCT Number: NCT07218705

A Study Of MCG In Cardiac Amyloidosis

The primary objective of this observational study is to evaluate the utility of magnetocardiography (MCG) in diagnosing and monitoring disease progression in patients with amyloidosis, and to assess its effectiveness in comparison to other modalities, such as ECG.

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Key information

Conditions

Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years on the date of consent
  • Ability for participant to comply with study requirements
  • Written informed consent

Exclusion criteria

  • Pregnant or breastfeeding
  • Having an active atrial fibrillation episode as seen on most current 12-lead ECG
  • Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillator).
  • External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan
  • Inability to lie down in a supine/inclined position and stay still on the examination bed
  • Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol

Treatment and study plan

SandboxAQ CardiAQ Magnetocardiography

Device

Magnetocardiography is a non-invasive, radiation-free imaging technique that detects the magnetic field generated by the electrical activity of the heart.

Primary outcomes

  1. Receiver Operating Characteristic (ROC) curve

    Time frame: Baseline, 6 Months, 12 Months, 18 Months

    Receiver Operating Characteristic (ROC) curve is used to compare true positive rate vs false positive rate. This will be used to determine the sensitivity, specificity, and overall effectiveness of MCG.

  2. Area Under the Curve (AUC) Magnetocardiography

    Time frame: Baseline, 6 Months, 12 Months, 18 Months

    Area Under the Curve (AUC) will be measured by mg*h/L.

  3. Area Under the Curve (AUC) Electrocardiogram

    Time frame: Baseline, 6 Months, 12 Months, 18 Months

    Area Under the Curve (AUC) will be measured by mg*h/L.

Interested in participating?

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Interested in participating?

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Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Prospective Study of Magnetocardiography for Disease Detection and Monitoring Treatment Outcomes in Amyloidosis

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 20, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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