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NCT Number: NCT06255769

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

Location status: Recruiting

Location contact

YUGUO CHEN

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Magnetocardiography

Device

Magnetocardiography

Single photon emission computed tomography (SPECT)

Device

Single photon emission computed tomography (SPECT)

Primary outcomes

  1. 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

    Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.

Secondary outcomes

  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

    Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.

Study contacts

Contact information is provided by the study sponsor or research team.

Jiaojiao Pang, Doctor

CONTACT

[email protected]

0086-0531-82165398

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Collaborators

  • Chongqing Emergency Medical Center

Registry information

Official study title

Identification of Myocardial Ischemia With Magnetocardiography Using Single Photon Emission Computed Tomography (SPECT) as a Reference Standard

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Feb 13, 2024
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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