NCT05392712

Brief Summary

Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting myocardial ischemia. Although progress has been made in this area, there is a lack of studies using up-to-date examination instruments for the calibration of MCG analysis. This is a prospective single-center study aiming to build accurate analytical models of MCG to detect coronary lesions and myocardial necrosis. Coronary lesions are measured by coronary angiography (CAG) or coronary CTA, and are defined by both the stenosis degree and the computer-simulated fraction flow reserve. Myocardial necrosis is examined and quantified by cardiac MR. Healthy volunteers, chest pain patients who will receive CAG or CTA examination, and patients with acute myocardial infarction will be enrolled in this study.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
430

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 26, 2022

Completed
4 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

August 22, 2024

Status Verified

May 1, 2024

Enrollment Period

2.3 years

First QC Date

May 23, 2022

Last Update Submit

August 20, 2024

Conditions

Chest Pain, Acute Coronary Syndrome, Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

  • Accuracy of MCG to detect coronary lesion

    To establish an algorithm model of MCG in detecting coronary lesion and to assess the sensitivity and specificity of the above model in detecting coronary lesion. Coronary lesion is measured by degree of stenosis via CAG/CTA and computer-simulated fraction flow reserve via QFR/CTFFR.

    24 hours

  • Accuracy of MCG to detect myocardial necrosis

    To establish an algorithm model of MCG in detecting myocardial necrosis and to assess the sensitivity and specificity of this model in detecting myocardial necrosis, which is measured via cardiac MR.

    24 hours

Secondary Outcomes (2)

  • Accuracy of MCG to detect the localization of coronary lesion

    24 hours

  • Accuracy of MCG to detect the zone of myocardial necrosis

    24 hours

Study Arms (3)

healthy volunteers

OTHER
Device: Magnetometer

Chest pain patients who will undergo CAG or CTA

EXPERIMENTAL
Device: Magnetometer

AMI patients

EXPERIMENTAL
Device: Magnetometer

Interventions

MagnetometerDEVICE

inspection equipment for magnetocardiography

AMI patientsChest pain patients who will undergo CAG or CTAhealthy volunteers

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-79 years old;
  • No history of cardiovascular disease (coronary heart disease, structural heart disease, arrhythmia, heart failure, stroke, pulmonary embolism, aortic dissection, etc.), no cardiovascular risk factors (hypertension, diabetes, hyperlipidemia). For people over 65 years old, those with hypertension or hyperlipidemia, but with well-controlled blood pressure and lipid levels, taking no more than 2 drugs, and echocardiography showing no left ventricular hypertrophy, can be included;
  • The electrocardiogram is normal, and the cardiac ultrasound is basically normal in the past 1 year (mild valvular regurgitation can be included).
  • Sign the informed consent.

You may not qualify if:

  • Those who with acute or chronic respiratory diseases;
  • Those who with obvious abnormality of liver or kidney function;
  • Those who with endocrine diseases such as abnormal thyroid function;
  • Those who with anemia or other blood diseases;
  • Those who with connective tissue diseases (lupus erythematosus, rheumatoid arthritis, dermatomyositis, polyarteritis nodosa, etc.);
  • Those who are obese (BMI\>30kg/cm2) or underweight (BMI\<18kg/cm2);
  • Those who with malignant tumors;
  • Those who with infectious diseases or infectious diseases;
  • Those who with trauma or physical disability;
  • Those who with psychological or mental illness such as depression;
  • Those who are professional athletes, pregnant or breastfeeding women, alcoholics;
  • Those who are unable to perform magnetocardiography examination due to claustrophobia, etc., or those who fail to receive magnetocardiography examination;
  • Due to various reasons such as allergy to contrast agents, metal implants in vivo that are prohibited from performing 1.5T MRI (such as prostheses or steel plates implanted in orthopaedics, uterine contraceptive device) and other reasons, those who cannot or fail to cooperate with the corresponding research requirements.
  • For chest pain patients who will undergo CAG or CTA:
  • Age 18-79 years old;
  • +30 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Chest PainAcute Coronary SyndromeMyocardial Infarction

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesNecrosis

Study Officials

  • Yuguo Chen, Dr

    Qilu Hospital of Shandong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiaojiao Pang, Dr.

CONTACT

0086-0531-82165674jiaojiaopang@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2022

First Posted

May 26, 2022

Study Start

May 30, 2022

Primary Completion

August 30, 2024

Study Completion

December 30, 2024

Last Updated

August 22, 2024

Record last verified: 2024-05

Locations

CN(1)