Diagnosis of Myocardial Ischemia With MCG Using SPECT as a Reference Standard
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial population
Chest pain patients who have CAG showing \<70% stenosis at the most severe site or CTA showing non-severe stenosis
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Magnetocardiography
DeviceMagnetocardiography
Single photon emission computed tomography (SPECT)
DeviceSingle photon emission computed tomography (SPECT)
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
from the date of enrollment until the date of discharge, up to 30 daysSecondary outcomes
1
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.
Time frame
from the date of enrollment until the date of discharge, up to 30 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
Qilu Hospital of Shandong University
Lead sponsor
Chongqing Emergency Medical Center
Collaborator
Source ClinicalTrials.gov