Research on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography

Research on Diagnosis and Prognosis of Myocardial Ischemia Level in Xiangya Hospital Using Magnetocardiography -- Miracle MCG

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
• Intervention / Treatment: Device: Magnetocardiography

• Study Type: Interventional
• Enrollment (Anticipated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Liu; Phone Number: 86-18932462423; Email: 208111002@csu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Control	Device: Magnetocardiography; Both arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently.
EXPERIMENTAL: Coronary stenosis	Device: Magnetocardiography; Both arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse cardiovascular events	Participants are followed up by telephone at 1, 3, 6, 12, 24, 36, 48, and 60 months after recruitment and ask whether major adverse cardiac events (MACE) have happened. MACE will be defined as acute myocardial infarction, coronary revascularization, stroke, and all-cause death. According to incidence of MACE, draw the Kaplan-Meier curve and establish Cox regression model.Establish a risk-predicted model of MCG for detecting myocardial infarction	through study completion, an avarage of 2 years

Collaborators and Investigators

• Sponsor: Xiangya Hospital of Central South University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 15, 2023
• Primary Completion (ANTICIPATED): August 14, 2023
• Study Completion (ANTICIPATED): August 14, 2025

Study Registration Dates

• First Submitted: December 25, 2022
• First Submitted That Met QC Criteria: January 29, 2023
• First Posted (ACTUAL): February 8, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: January 29, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Ischemia; Acute Coronary Syndrome
• Other Study ID Numbers: 202209584

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No