A Study Of MCG In Cardiac Amyloidosis

Mayo Clinic500 enrolled

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

Amyloidosis

Interventions

SandboxAQ CardiAQ MagnetocardiographyDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Mayo Clinic in Rochester

Rochester, Minnesota, United States

RECRUITING

Outcomes

Primary Outcomes

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

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

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

Central Contacts

Andy Dang

CONTACT

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

Data from ClinicalTrials.gov

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