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

NCT ID: NCT06255769

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

228 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-12

Study Completion Date

2024-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chest Pain Stenosis Myocardial Ischemia

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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Magnetocardiography

Magnetocardiography

Intervention Type DEVICE

Single photon emission computed tomography (SPECT)

Single photon emission computed tomography (SPECT)

Intervention Type DEVICE

Eligibility Criteria

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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, â…¡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;
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Emergency Medical Center

OTHER

Sponsor Role collaborator

Qilu Hospital of Shandong University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yuguo Chen, Professor

Role: PRINCIPAL_INVESTIGATOR

Qliu Hospital of Shandong University

Locations

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Qilu Hospital of Shandong University

Jinan, Shandong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Jiaojiao Pang, Doctor

Role: CONTACT

0086-0531-82165398

Facility Contacts

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YUGUO CHEN

Role: primary

Other Identifiers

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MCG-SPECT

Identifier Type: -

Identifier Source: org_study_id

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