Health TrialsbyHealthPanel

A Study Of MCG In Cardiac Amyloidosis

ConditionAmyloidosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 18 years on the date of consent

Ability for participant to comply with study requirements

Written informed consent

Disqualifiers

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

Trial 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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Patients with amyloidosis1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 6 Months, 12 Months, 18 Months
2

Area Under the Curve (AUC) Magnetocardiography

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

Time frame
Baseline, 6 Months, 12 Months, 18 Months
3

Area Under the Curve (AUC) Electrocardiogram

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

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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