MCG for Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorQilu Hospital of Shandong University
About this trial
The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age 18 years or older;
Patients with symptoms of myocardial ischemia such as angina who are suspected to NSTE-ACS and proposed to undergo CAG or coronary CTA;
Signed informed consent.
Disqualifiers
Patients with ST-elevation myocardial infarction (STEMI);
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, Ⅱ 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;
Trial population
chest pain patients with suspected NSTE-ACS
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Magnetocardiography
DeviceMagnetocardiography
Treatment groups
14,090 Participants
are divided into 2 treatment groupsGroup A: Training and testing cohort1 intervention
Group B: External validation cohort1 intervention
Trial outcomes
Primary outcomes
1
Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS
the sensitivity and specificity of MCG to detect coronary ischemia (defined as stenosis ≥ 90% or fractional flow reserve ≤0.8）
Time frame
from the date of enrollment until the date of discharge, up to 30 daysSecondary outcomes
1
Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.
A normal ECG is determined by two cardiologists with over five years of working experience. If there is any objection, the decision shall be made by a third cardiologist of the same qualifications or above. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.
Time frame
from the date of enrollment until the date of discharge, up to 30 days2
The time saved by using MCG in the detection of NSTEMI compared to troponin
The time for the detection of NSTEMI is from the timepoint of first medical contact to the timepoint of MCG report showing ischemia or the first report of troponin that over the 99th percentile of the Upper reference limit (URL).
Time frame
from the date of enrollment until the date of discharge, up to 30 days3
Efficacy of MCG in evaluating the severity of coronary lesions.
The severity of coronary lesions is determined by using CAG/CTA and fractional flow reserve. Severe degree is defined as ≥90% stenosis of at least one main vessel or branch vessel with diameter ≥2mm. Moderate degree is defined as 50%-89% stenosis and fractional flow reserve ≤0.8. Mild degree is defined as \<50% stenosis and fractional flow reserve ≤0.8, or stenosis 50%-89% and fractional flow reserve\> 0.8. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy.
Time frame
from the date of enrollment until the date of discharge, up to 30 days4
Efficacy of MCG in early stratification of patients with suspected NSTE-ACS
For early stratification measurement, patients with suspected NSTE-ACS are assessed by 30d (from enrollment) MACE and classified as high or low risk. Sensitivity, specificity, and area under ROC curve (AUC) are performed for assessing the efficacy of MCG.
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
Linyi People's Hospital
Collaborator
Weifang People's Hospital
Collaborator
Jining First People's Hospital
Collaborator
Weihai Central Hospital
Collaborator
The First Affiliated Hospital with Nanjing Medical University
Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborator
First Affiliated Hospital Xi'an Jiaotong University
Collaborator
First People's Hospital of Hangzhou
Collaborator
Chongqing Emergency Medical Center
Collaborator
Guangdong Provincial Hospital of Traditional Chinese Medicine
Collaborator
Qianfoshan Hospital
Collaborator
Heze Municipal Hospital
Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Collaborator
Source ClinicalTrials.gov