An Exploratory Clinical Study to Evaluate the Specificity of Magnetocardiogram in Atrial Fibrillation and the Prediction of Recurrence

NCT05887453 | Unknown

• 1 other identifier: JWang
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational clinical study with150 patients of persistent AF (trial group 1), 150 patients of paroxysmal AF (trial group 2), and 150 healthy subjects (control group). The trial is divided into two parts. The aim of first part is to evaluate the sensitivity and specificity of magnetocardiography on diagnosing persistent AF, and the second part is to evaluate the independent predictors of magnetocardiography on predicting recurrence of paroxysmal AF. The patients who had been diagnosed with AF in OPD or IPD will be included. After signing the informed consent letter, medical history of all subjects will be collected, including magnetic cardiogram, 12-lead electrocardiogram, holter electrocardiogram, cardiac ultrasound and blood tests. Patients with paroxysmal AF will be followed up for 3 months, and the recurrence of AF is the observation end point.

Conditions

Atrial Fibrillation

Outcome Measures

Primary Outcomes (2)

• sensitivity and specificity

  The sensitivity and specificity of magnetocardiography in the diagnosis of persistent AF

  24 hours

• Independent predictors of recurrence of paroxysmal atrial fibrillation

  A statistical model is used to obtain the magnetocardiographic parameters that could predict the recurrence of paroxysmal atrial fibrillation.

  3 months

Study Arms (3)

Group 1: Persistent AF

Device: Magnetocardiography

Group 2 : Paroxysmal AF

Device: Magnetocardiography

Healthy controls

Device: Magnetocardiography

Interventions

Magnetocardiography DEVICE

Magnetocardiography is a device used to exam the dynamic magnetic map of the heart for the diagnosis of some heart diseases

Group 1: Persistent AF; Group 2 : Paroxysmal AF; Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with atrial fibrillation and healthy people without arrhythmia

You may qualify if:

• Persistent AF is recorded by ECG before the examination of the magnetocardiogram;
• Detailed clinical records, including medical history, cardiovascular risk factors, blood tests, and antiarrhythmic drug therapy;
• It is recommended that antiarrhythmic drugs be discontinued at least 5 days before the examination and continue if atrial fibrillation occurs or the symptoms of atrial fibrillation are obvious;

You may not qualify if:

• Severe valvular heart disease, structural heart disease, heart function classification ≥ New York Heart Association functional class II, history of ischemic heart disease, left ventricular ejection fraction \< 50%, hyperthyroidism, primary pulmonary hypertension, and respiratory disease;
• Patients after radiofrequency ablation;
• The implanted devices in the body effect the magnetic signal during the detection process, such as prosthetic limbs, heart stents or valves contain metal material.
• Unable to maintain the supine position during the examination.
• Group: Group 2 (Paroxysmal AF)
• Persistent AF is recorded by ECG before the examination of the magnetocardiogram;
• Detailed clinical records, including medical history, cardiovascular risk factors, blood tests, and antiarrhythmic drug therapy;
• It is recommended that antiarrhythmic drugs be discontinued at least 5 days before the examination and continue if atrial fibrillation occurs or the symptoms of atrial fibrillation are obvious;
• Severe valvular heart disease, structural heart disease, heart function classification ≥ New York Heart Association functional class II, history of ischemic heart disease, left ventricular ejection fraction \< 50%, hyperthyroidism, primary pulmonary hypertension, and respiratory disease;
• Patients after radiofrequency ablation;
• The implanted devices in the body effect the magnetic signal during the detection process, such as prosthetic limbs, heart stents or valves contain metal material.
• Unable to maintain the supine position during the examination.
• Group: Control group
• No history of AFor other arrhythmias;
• Detailed clinical records, including medical history and cardiovascular risk factors;

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Magnetocardiography

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques

Study Officials

• Jian'an Wang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jian'an Wang

CONTACT

+86-13805786328; wangjianan111@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2023
• First Posted: June 2, 2023
• Study Start: March 22, 2023
• Primary Completion: August 1, 2023
• Study Completion: December 1, 2023
• Last Updated: June 2, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)