Clinical trial NCT05718206: 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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stable Ischemic Heart Disease; Acute Coronary Syndrome; Myocardial Infarction; Myocardial Ischemia
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity of diagnosis of myocardial infarction level
timeFrame: up to 6 months
measure: Specificity of diagnosis of myocardial infarction level
timeFrame: up to 6 months
measure: Consistency of diagnosis of myocardial infarction level
timeFrame: up to 6 months
measure: Kappa statistics of diagnosis of myocardial infarction level
timeFrame: up to 6 months
Secondary outcomes:
measure: Incidence of major adverse cardiovascular events
timeFrame: through study completion, an avarage of 2 years
Other outcomes:
Locations:
Study officials:
References: