MCG for Localization of Tachyarrhythmia's Origin

August 19, 2024 updated by: Qilu Hospital of Shandong University

Magnetocardiography for Precise Identification of the Site of Origin of Tachyarrhythmia

This is an exploratory research aiming to accurately identify the site of origin of tachyarrhythmia using Magnetocardiography (MCG), which will have guiding significance for early diagnosis, the formulation of treatment plans and preoperative positioning for radiofrequency ablation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • China, Shandong Qilu Hospital of Shandong University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18-79 years old;
  • Those whose conditions are comparatively stable and who have been diagnosed by an attending physician （or physicians with higher qualifications） with paroxysmal supraventricular tachycardia, atrial tachycardia, atrial flutter, atrial fibrillation, or premature ventricular contractions, and who are capable of performing MCG and cardiac electrophysiologic examinations after evaluation.
  • Signed informed consent.

Exclusion Criteria:

  • Those with known structural heart disease such as cardiomyopathy and valvular disease;
  • Those with history of other cardiovascular diseases such as pulmonary embolism and aortic dissection;
  • Those with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.) combined with cardiac complications;
  • Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
  • Those with Obese (BMI>30kg/cm2) or underweight (BMI<18kg/cm2);
  • Those with malignant tumors;
  • Professional athletes, pregnant or breastfeeding women, alcoholics;
  • Those with acute diseases or critical illnesses in other systems, such as acute or severe respiratory diseases, abnormal liver function or renal function, etc.;
  • Those with infectious diseases or communicable diseases;
  • Those who are unable or fail to perform magnetocardiography due to claustrophobia, physical impairment, etc.;
  • Unable to or fail to cooperate with the corresponding research requirements.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients with atrial tachycardia
Patients with atrial tachycardia will receive dynamic ECG, MCG and cardiac electrophysiologic examinations.
Device: Magnetocardiography
Magnetocardiography
Experimental: Patients with atrial flutter
Patients with atrial flutter will receive dynamic ECG, MCG and cardiac electrophysiologic examinations.
Device: Magnetocardiography
Magnetocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of MCG to detect the site of origin of Tachyarrhythmia using cardiac electrophysiology as a reference standard.
Time Frame: 12 month course of the disease
Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.
12 month course of the disease

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Investigators

  • Principal Investigator: Yuguo Chen, Professor, Qliu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

March 11, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

August 21, 2024

Last Update Submitted That Met QC Criteria

August 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCG-Tachyarrhythmia

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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