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

NCT06255769 | Recruiting DMC

• 1 other identifier: MCG-SPECT
• Study Type: observational
• Target: 228
• Locations: 1 country
• Sites: 1

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.

Conditions

Chest Pain; Stenosis; Myocardial Ischemia

Outcome Measures

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.

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

Secondary Outcomes (1)

• 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

Interventions

Magnetocardiography DEVICE

Magnetocardiography

Single photon emission computed tomography (SPECT) DEVICE

Single photon emission computed tomography (SPECT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Chest pain patients who have CAG showing \<70% stenosis at the most severe site or CTA showing non-severe stenosis

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead
• Chongqing Emergency Medical Center: collaborator

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Chest Pain; Constriction, Pathologic; Myocardial Ischemia

Interventions

Magnetocardiography; Tomography, Emission-Computed, Single-Photon

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathological Conditions, Anatomical; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Electrodiagnosis; Magnetometry; Investigative Techniques; Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Yuguo Chen, Professor

  Qliu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Pang, Doctor

CONTACT

0086-0531-82165398; jiaojiaopang@126.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: February 13, 2024
• Study Start: February 12, 2024
• Primary Completion: October 31, 2024
• Study Completion: December 31, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

CN (1)