A Study Of MCG In Cardiac Amyloidosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SandboxAQ CardiAQ Magnetocardiography.
- Who it may be relevant to
- Registry conditions: Amyloidosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Prospective Study of Magnetocardiography for Disease Detection and Monitoring Treatment Outcomes in Amyloidosis
Overview
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
- Device SandboxAQ CardiAQ Magnetocardiography
Magnetocardiography is a non-invasive, radiation-free imaging technique that detects the magnetic field generated by the electrical activity of the heart.
Primary outcome measures
- Receiver Operating Characteristic (ROC) curve [Time frame: Baseline, 6 Months, 12 Months, 18 Months]
- Area Under the Curve (AUC) Magnetocardiography [Time frame: Baseline, 6 Months, 12 Months, 18 Months]
- Area Under the Curve (AUC) Electrocardiogram [Time frame: Baseline, 6 Months, 12 Months, 18 Months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07218705 · 25-005053