Diagnosis of Myocardial Ischemia With MCG Using SPECT as a Reference Standard

Myocardial Ischemia Clinical Trial

Official title:

Identification of Myocardial Ischemia With Magnetocardiography Using Single Photon Emission Computed Tomography (SPECT) as a Reference Standard

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06255769
• Other study ID #: MCG-SPECT
• Status: Not yet recruiting
• Start date: February 12, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• 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

This is a prospective clinical study aiming to investigate the efficacy of Magnetocardiography (MCG) in detecting myocardial ischemia in patients of a suspected non-ST-elevation-acute coronary syndrome (NSTE-ACS) by using Single photon emission computed tomography (SPECT) as the gold standard for determining the presence and severity of myocardial ischemia.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 228
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 years or older;
• Patients with symptoms of myocardial ischemia such as angina pectoris, who have CAG showing <70% stenosis at the most severe site or CTA showing non-severe stenosis
• Signed informed consent.

Exclusion Criteria:

• Patients with absolute or relative contraindications to SPECT-loaded myocardial perfusion, including acute myocardial infarction within 48 hours, significant left main coronary artery stenosis, bronchial asthma, and adenosine injection allergy;
• Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;
• 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;
• Patients who have severe renal abnormality with eGFR <30 ml/min, or patients who are on dialysis;
• Patients with malignant tumors with predicted survival of less than 1 year;
• Pregnant or breastfeeding women;
• 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

• Chest Pain
• Coronary Artery Disease
• Ischemia
• Myocardial Ischemia
• Stenosis

Intervention

Device:
• Magnetocardiography
Magnetocardiography
• Single photon emission computed tomography (SPECT)
Single photon emission computed tomography (SPECT)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of MCG to detect myocardial ischemia using SPECT as a reference standard.	Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.	from the date of enrollment until the date of discharge, up to 30 days
Secondary	Efficacy of MCG to detect myocardial ischemia in patients with coronary stenosis <50% (Ischemia with no obstructive coronary artery, INOCA)	Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.	from the date of enrollment until the date of discharge, up to 30 days