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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06255769
Enrollment
228
Registered
2024-02-13
Start date
2024-02-12
Completion date
2024-12-31
Last updated
2024-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Pain, Stenosis, Myocardial Ischemia

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.

Interventions

Magnetocardiography

Single photon emission computed tomography (SPECT)

Sponsors

Chongqing Emergency Medical Center
CollaboratorOTHER
Qilu Hospital of Shandong University
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Efficacy of MCG to detect myocardial ischemia using SPECT as a reference standard.from the date of enrollment until the date of discharge, up to 30 daysSensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.

Secondary

MeasureTime frameDescription
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 daysSensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.

Countries

China

Contacts

Primary ContactJiaojiao Pang, Doctor
jiaojiaopang@126.com0086-0531-82165398

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026