Back to resultsResearch on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography
Primary Purpose
Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Magnetocardiography
Sponsored by
About this trial
This is an interventional diagnostic trial for Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
Eligibility Criteria
Inclusion Criteria: Age ≥18 years old; Those who are suspected of coronary heart disease and scheduled to undergo coronary angiography; Sign the informed consent. Exclusion Criteria: 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; Those who aren't suitable for inclusion due to other reason.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Coronary stenosis
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05718206
First Posted
December 25, 2022
Last Updated
January 29, 2023
Sponsor
Xiangya Hospital of Central South University
1. Study Identification
Unique Protocol Identification Number
NCT05718206
Brief Title
Research on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography
Official Title
Research on Diagnosis and Prognosis of Myocardial Ischemia Level in Xiangya Hospital Using Magnetocardiography -- Miracle MCG
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 15, 2023 (Anticipated)
Primary Completion Date
August 14, 2023 (Anticipated)
Study Completion Date
August 14, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xiangya Hospital of Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
146 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Coronary stenosis
Arm Type
Experimental
Arm Title
Control
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Magnetocardiography
Intervention Description
Both arms underwent magnetocardiogram examination, and three experts interpreted magnetocardiogram results independently.
Primary Outcome Measure Information:
Title
Sensitivity of diagnosis of myocardial infarction level
Description
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.
Time Frame
up to 6 months
Title
Specificity of diagnosis of myocardial infarction level
Description
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.
Time Frame
up to 6 months
Title
Consistency of diagnosis of myocardial infarction level
Description
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.
Time Frame
up to 6 months
Title
Kappa statistics of diagnosis of myocardial infarction level
Description
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.
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
Incidence of major adverse cardiovascular events
Description
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
Time Frame
through study completion, an avarage of 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥18 years old;
Those who are suspected of coronary heart disease and scheduled to undergo coronary angiography;
Sign the informed consent.
Exclusion Criteria:
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;
Those who aren't suitable for inclusion due to other reason.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jie Liu
Phone
86-18932462423
Email
208111002@csu.edu.cn
12. IPD Sharing Statement
Learn more about this trial
Research on Diagnosis and Prognosis of Myocardial Ischemia Level Using Magnetocardiography
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