Diagnosis of Myocardial Ischemia With MCG Using SPECT as a Reference Standard
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Magnetocardiography, Single photon emission computed tomography (SPECT).
- Who it may be relevant to
- Registry conditions: Chest Pain, Stenosis, Myocardial Ischemia. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Identification of Myocardial Ischemia With Magnetocardiography Using Single Photon Emission Computed Tomography (SPECT) as a Reference Standard
Overview
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
- Device Magnetocardiography
Magnetocardiography - Device Single photon emission computed tomography (SPECT)
Single photon emission computed tomography (SPECT)
Primary outcome measures
- 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]
Secondary outcome measures (1)
- Efficacy of MCG to detect myocardial ischemia in patients with coronary stenosis <50% (Ischemia with no obstructive coronary artery, INOCA) [Time frame: from the date of enrollment until the date of discharge, up to 30 days]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 1 center
- Qilu Hospital of Shandong University — Jinan
Identifiers
NCT: NCT06255769 · MCG-SPECT