Amyloidosis
Conditions
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.
Interventions
DEVICESandboxAQ CardiAQ Magnetocardiography
Magnetocardiography is a non-invasive, radiation-free imaging technique that detects the magnetic field generated by the electrical activity of the heart.
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥ 18 years on the date of consent 2. Ability for participant to comply with study requirements 3. Written informed consent
Exclusion criteria
1. Pregnant or breastfeeding 2. Having an active atrial fibrillation episode as seen on most current 12-lead ECG 3. Active thoracic metal implants (including pacemaker, insertable cardiac monitor, or internal defibrillator). 4. External electrical pads or devices (e.g. Pacer pads, ECG electrodes, heart rate patch), that must remain on patient's chest during MCG scan 5. Inability to lie down in a supine/inclined position and stay still on the examination bed 6. Clinical conditions that in the opinion of the Investigator would compromise the safety of the patient or ability to complete the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receiver Operating Characteristic (ROC) curve | 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. |
| Area Under the Curve (AUC) Magnetocardiography | Baseline, 6 Months, 12 Months, 18 Months | Area Under the Curve (AUC) will be measured by mg\*h/L. |
| Area Under the Curve (AUC) Electrocardiogram | Baseline, 6 Months, 12 Months, 18 Months | Area Under the Curve (AUC) will be measured by mg\*h/L. |
Countries
United States
Contacts
Primary ContactAndy Dang
Outcome results
None listed