A Study Of MCG In Cardiac Amyloidosis

NCT07218705 | Recruiting

• 1 other identifier: 25-005053
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amyloidosis

Outcome Measures

Primary Outcomes (3)

• Receiver Operating Characteristic (ROC) curve

  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.

  Baseline, 6 Months, 12 Months, 18 Months

• Area Under the Curve (AUC) Magnetocardiography

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

  Baseline, 6 Months, 12 Months, 18 Months

• Area Under the Curve (AUC) Electrocardiogram

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

  Baseline, 6 Months, 12 Months, 18 Months

Study Arms (1)

Patients with amyloidosis

Device: SandboxAQ CardiAQ Magnetocardiography

Interventions

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.

Patients with amyloidosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study candidates may be identified and recruited in one of the following ways: * Amyloid Clinic (or other cardiology specialty clinics) * In-patient service at the study institution. * From the Principal Investigator or Co-Investigator clinical practices * Referral from other hospitals

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

MeSH Terms

Conditions

Amyloidosis

Condition Hierarchy (Ancestors)

Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohamad Alkhouli, M.D., M.B.A.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andy Dang

CONTACT

507-255-7752; dang.phong@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 16, 2025
• First Posted: October 20, 2025
• Study Start: December 3, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)