ClinicalTrials.gov record NCT07218705
A Study Of MCG In Cardiac Amyloidosis
A Prospective Study of Magnetocardiography for Disease Detection and Monitoring Treatment Outcomes in Amyloidosis
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This observational study will evaluate magnetocardiography (MCG) for detecting and monitoring cardiac amyloidosis and compare its measurements with electrocardiography (ECG). Participants will have MCG and ECG assessments at baseline and at scheduled follow-ups up to 18 months. The study will analyze test performance using ROC curves and area under the curve (AUC).
What it is studying. Whether magnetocardiography can detect cardiac amyloidosis and track disease changes over time, compared with standard ECG measurements.
What the researchers hope to learn. To measure and compare the diagnostic and monitoring performance of MCG and ECG for cardiac amyloidosis using ROC curves and AUC at baseline, 6, 12, and 18 months.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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 being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Device
- SandboxAQ CardiAQ Magnetocardiography
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
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
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants will have non‑invasive, radiation‑free magnetocardiography (MCG) scans using the SandboxAQ CardiAQ device and standard electrocardiograms at baseline and at 6, 12, and 18 months. Scans require lying on an examination bed in a supine or inclined position and staying still during the recording. The study collects MCG and ECG measurements over time to compare their performance; no invasive procedures are listed in the registry. You will need to provide written informed consent and follow study instructions; investigators may exclude participants for safety or protocol‑completion concerns.
How the study is structured. A prospective observational cohort study. People with amyloidosis will undergo MCG and ECG testing at baseline and again at 6, 12, and 18 months to compare results over time.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on wild-type ATTR amyloidosis
Important dates
- Study start
- Dec 3, 2025
- Primary completion
- November 2027 (estimated)
- Study completion
- November 2027 (estimated)
- Target enrollment
- 500 participants (estimated)
- Last updated on registry
- Dec 22, 2025
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Mayo Clinic
- Principal investigator
- Mohamad Adnan Alkhouli, Principal Investigator
Mayo Clinic
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Andy Dang 📞 507-255-7752 ✉ dang.phong@mayo.edu
Participating sites (1)
- Mayo Clinic in RochesterRecruiting
Rochester, Minnesota, 55905 · United States
- Structural Heart Research Team · (507) 255-6133 · konwinski.craig@mayo.edu
- Mohamad Adnan Alkhouli, MD
Terms used on this page · explanations by MedicalUpdates.ai
- primary objective
- The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
- ECG
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- Written informed consent
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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