MCG for Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients

Non ST Segment Elevation Acute Coronary Syndrome Clinical Trial

Official title:

Magnetocardiography as an Innovative Diagnostic Tool for Early and Accurate Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06197724
• Other study ID #: MCG-NSTEACS
• Status: Not yet recruiting
• Start date: January 2, 2024
• Est. completion date: January 31, 2025

Study information

• Verified date: December 2023
• Source: Qilu Hospital of Shandong University
• Contact: Jiaojiao Pang, Doctor
• Phone: 0086-0531-82165398
• Email: jiaojiaopang[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2224
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, ? 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.

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Non ST Segment Elevation Acute Coronary Syndrome

Intervention

Device:
• Magnetocardiography
Magnetocardiography

Locations

Country	Name	City	State
China	Qilu Hospital of Shandong University	Jinan	Shandong

Sponsors (16)

Lead Sponsor

Collaborator

Qilu Hospital of Shandong University

Dezhou People's Hospital, First Affiliated Hospital Xi'an Jiaotong University, First People's Hospital of Hangzhou, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hangzhou Extremely Weak Magnetic Field Large Facility Research Institute, Jining First People's Hospital, Linyi People's Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, The Affiliated Hospital of Hangzhou Normal University, The First Affiliated Hospital of Zhejiang Chinese Medical University, The First Affiliated Hospital with Nanjing Medical University, Weifang People's Hospital, Weihai Municipal Hospital, Zhongda Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS	the sensitivity and specificity of MCG to detect coronary ischemia (defined as stenosis = 90% or fractional flow reserve =0.8)	from the date of enrollment until the date of discharge, up to 30 days
Secondary	Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.	A normal ECG is determined by two cardiologists with over five years of working experience. If there is any objection, the decision shall be made by a third cardiologist of the same qualifications or above. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.	from the date of enrollment until the date of discharge, up to 30 days
Secondary	The time saved by using MCG in the detection of NSTEMI compared to troponin	The time for the detection of NSTEMI is from the timepoint of first medical contact to the timepoint of MCG report showing ischemia or the first report of troponin that over the 99th percentile of the Upper reference limit (URL).	from the date of enrollment until the date of discharge, up to 30 days
Secondary	Efficacy of MCG in evaluating the severity of coronary lesions.	The severity of coronary lesions is determined by using CAG/CTA and fractional flow reserve. Severe degree is defined as =90% stenosis of at least one main vessel or branch vessel with diameter =2mm. Moderate degree is defined as 50%-89% stenosis and fractional flow reserve =0.8. Mild degree is defined as <50% stenosis and fractional flow reserve =0.8, or stenosis 50%-89% and fractional flow reserve> 0.8. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.	from the date of enrollment until the date of discharge, up to 30 days
Secondary	Efficacy of MCG in early stratification of patients with suspected NSTE-ACS	For early stratification measurement, patients with suspected NSTE-ACS are assessed by 30d (from enrollment) MACE and classified as high or low risk. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy of MCG.	from the date of enrollment until the date of discharge, up to 30 days