Clinical trial NCT06197724: MCG for Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients
Official title: Magnetocardiography as an Innovative Diagnostic Tool for Early and Accurate Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non ST Segment Elevation Acute Coronary Syndrome
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Linyi People's Hospital
name: Weifang People's Hospital
name: Jining First People's Hospital
name: Weihai Central Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: First Affiliated Hospital Xi'an Jiaotong University
name: First People's Hospital of Hangzhou
name: Chongqing Emergency Medical Center
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Qianfoshan Hospital
name: Heze Municipal Hospital
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
First posted: 2024-01-09
Enrollment: 2224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chest pain patients with suspected NSTE-ACS

Brief summary: The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS.

Detailed description: Rapid and accurate Identification of ischemia in patients with chest pain suspected of non-ST-elevation-acute coronary syndrome (NSTE-ACS) is of great clinical significance for timely and effective treatment. Magnetocardiography based on spin-exchange relaxation-free (SERF) principle can detect the weak magnetic field generated by the heart sensitively, which do not need ultra-low temperature cooling. Magnetic signal does not decay through the skin and tissues as electricity does, hence magnetocardiogram (MCG) contains more information of diagnostic value of ischemia. The aim of this observational study is to optimize and validate MCG models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of blood supply to myocardium, in patients who suffer from chest pain, and compare to routine diagnostic means.

Eligibility criteria: Inclusion Criteria:

1. Age 18 years or older;
2. Patients with symptoms of myocardial ischemia such as angina who are suspected to NSTE-ACS and proposed to undergo CAG or coronary CTA;
3. Signed informed consent.

Exclusion Criteria:

1. Patients with ST-elevation myocardial infarction (STEMI);
2. Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;
3. Patients with Hemodynamic instability (systolic blood pressure\<90 mmHg, or who requires vasoactive drugs), or patients with tachyarrhythmia, Ⅱ degree atrioventricular block and above that have not returned to normal;
4. Patients who have severe renal abnormality with eGFR \<30 ml/min, or patients who are on dialysis;
5. Patients with malignant tumors with predicted survival of less than 1 year;
6. Pregnant or breastfeeding women;
7. Patients who are unable to enter the MCG device, who are unable to perform MCG examination due to interference from metal implants or other reasons, or who are deemed by the investigators to be unsuitable for enrollment.

Primary outcomes:
measure: Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS
timeFrame: from the date of enrollment until the date of discharge, up to 30 days
Secondary outcomes:
measure: Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.
timeFrame: from the date of enrollment until the date of discharge, up to 30 days
measure: The time saved by using MCG in the detection of NSTEMI compared to troponin
timeFrame: from the date of enrollment until the date of discharge, up to 30 days
measure: Efficacy of MCG in evaluating the severity of coronary lesions.
timeFrame: from the date of enrollment until the date of discharge, up to 30 days
measure: Efficacy of MCG in early stratification of patients with suspected NSTE-ACS
timeFrame: from the date of enrollment until the date of discharge, up to 30 days
Other outcomes:
Locations:
city: Jinan
country: China
facility: Qilu Hospital of Shandong University
state: Shandong
Study officials:
affiliation: Qliu Hospital of Shandong University
name: Yuguo Chen, Professor
role: PRINCIPAL_INVESTIGATOR
References: