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

Qilu Hospital of Shandong University1 site in 1 country228 target enrollmentFebruary 12, 2024

ConditionsChest Pain Stenosis Myocardial Ischemia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Chest Pain
Sponsor: Qilu Hospital of Shandong University
Enrollment: 228
Locations: 1
Primary Endpoint: Efficacy of MCG to detect myocardial ischemia using SPECT as a reference standard.
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

February 12, 2024

End Date

December 31, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Qilu Hospital of Shandong University

Responsible Party

Sponsor

Eligibility Criteria

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, Ⅱdegree 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.

Outcomes

Primary Outcomes

Efficacy of MCG to detect myocardial ischemia using SPECT as a reference standard.

Time Frame: from the date of enrollment until the date of discharge, up to 30 days

Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.

Secondary Outcomes

Efficacy of MCG to detect myocardial ischemia in patients with coronary stenosis <50% (Ischemia with no obstructive coronary artery, INOCA)(from the date of enrollment until the date of discharge, up to 30 days)