Research on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography

NCT05718206 | Unknown

• 1 other identifier: 202209584
• Study Type: interventional
• Target: 146
• Locations: 0 countries
• Sites: N/A

Brief Summary

Magnetocardiography (MCG) is a non-invasive and accurate method of detecting myocardial ischemia. However, the previous MCG is limited in clinical practice due to its high working conditions and limited sensitivity. The next-generation MCG based on optical pumped magnetometer (OPM) has the advantages of high sensitivity, high reliability, high usability and low cost, which makes it suitable for most medical scenarios. Thus, this prospective single-center study aimed to use OPM MCG to explore its diagnostic efficacy and predictive value for myocardial ischemia. Participants who will receive coronary angiography examinations will be enrolled in this study. Participants enrolled in the study will also have a 1, 3, 6, 12, 24, 36, and 48-month follow-up for analysis of adverse cardiac events.

Conditions

Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia

Outcome Measures

Primary Outcomes (4)

• Sensitivity of diagnosis of myocardial infarction level

  The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. And calculate the sensitivity to evaluate the diagnosis of myocardial infarction level validity.

  up to 6 months

• Specificity of diagnosis of myocardial infarction level

  The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. And calculate the specificity to evaluate the diagnosis of myocardial infarction level validity.

  up to 6 months

• Consistency of diagnosis of myocardial infarction level

  The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. Calculate the consistency to evaluate the diagnosis of myocardial infarction level reliability.

  up to 6 months

• Kappa statistics of diagnosis of myocardial infarction level

  The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. Calculate the Kappa statistics to evaluate the diagnosis of myocardial infarction level reliability.

  up to 6 months

Secondary Outcomes (1)

• Incidence of major adverse cardiovascular events

  through study completion, an avarage of 2 years

Study Arms (2)

Coronary stenosis

EXPERIMENTAL

Device: Magnetocardiography

Control

OTHER

Device: Magnetocardiography

Interventions

Magnetocardiography DEVICE

Both arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently.

Control; Coronary stenosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old;
• Those who are suspected of coronary heart disease and scheduled to undergo coronary angiography;
• Sign the informed consent.

You may not qualify if:

• Complex arrhythmia, including frequent premature atrial beats, premature ventricular beats, atrial fibrillation, atrial flutter, and complete bundle branch block;
• Severe hypertension (\> 180/110 mmHg);
• Congenital heart diseases, valvular heart diseases, or implantation of pacemakers or drug pumps.
• Severe thoracic or pulmonary diseases, thoracic malformation, or history of thoracic surgery;
• Pregnant or breastfeeding women;
• Claustrophobia, or those who can't lie still for 2 minutes in a confined space;
• Allergy to contrast agent;
• Renal impairment: serum creatinine \> 2,0 mg/dl (176.8 μmol/L) or those who are receiving hemodialysis;
• Other diseases, including malignant tumors, organ transplantation, and candidates for organ transplantation;
• History of alcohol or drug abuse (cocaine, heroin, etc.);
• Participating in clinical studies of other drugs or devices without reaching the time limit for the primary endpoint;

Sponsors & Collaborators

• Xiangya Hospital of Central South University: lead

MeSH Terms

Conditions

Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia

Interventions

Magnetocardiography

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Jie Liu

CONTACT

86-18932462423; 208111002@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 25, 2022
• First Posted: February 8, 2023
• Study Start: February 15, 2023
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2025
• Last Updated: February 8, 2023

Record last verified: 2022-12