Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT06255769
Status:
RECRUITING
Last Update Posted:
2024-08-21
First Post:
2024-01-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnosis of Myocardial Ischemia With MCG Using SPECT as a Reference Standard
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D003251', 'term': 'Constriction, Pathologic'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053798', 'term': 'Magnetocardiography'}, {'id': 'D015899', 'term': 'Tomography, Emission-Computed, Single-Photon'}], 'ancestors': [{'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004568', 'term': 'Electrodiagnosis'}, {'id': 'D060306', 'term': 'Magnetometry'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D014055', 'term': 'Tomography, Emission-Computed'}, {'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011877', 'term': 'Radionuclide Imaging'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003947', 'term': 'Diagnostic Techniques, Radioisotope'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2024-01-30', 'studyFirstSubmitQcDate': '2024-02-04', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of MCG to detect myocardial ischemia using SPECT as a reference standard.', 'timeFrame': 'from the date of enrollment until the date of discharge, up to 30 days', 'description': 'Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.'}], 'secondaryOutcomes': [{'measure': 'Efficacy of MCG to detect myocardial ischemia in patients with coronary stenosis <50% (Ischemia with no obstructive coronary artery, INOCA)', 'timeFrame': 'from the date of enrollment until the date of discharge, up to 30 days', 'description': 'Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chest Pain', 'Stenosis', 'Myocardial Ischemia']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Chest pain patients who have CAG showing \\<70% stenosis at the most severe site or CTA showing non-severe stenosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older;\n* 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\n* Signed informed consent.\n\nExclusion Criteria:\n\n* 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;\n* Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;\n* 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;\n* Patients who have severe renal abnormality with eGFR \\<30 ml/min, or patients who are on dialysis;\n* Patients with malignant tumors with predicted survival of less than 1 year;\n* Pregnant or breastfeeding women;\n* 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.'}, 'identificationModule': {'nctId': 'NCT06255769', 'briefTitle': 'Diagnosis of Myocardial Ischemia With MCG Using SPECT as a Reference Standard', 'organization': {'class': 'OTHER', 'fullName': 'Qilu Hospital of Shandong University'}, 'officialTitle': 'Identification of Myocardial Ischemia With Magnetocardiography Using Single Photon Emission Computed Tomography (SPECT) as a Reference Standard', 'orgStudyIdInfo': {'id': 'MCG-SPECT'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Magnetocardiography', 'type': 'DEVICE', 'description': 'Magnetocardiography'}, {'name': 'Single photon emission computed tomography (SPECT)', 'type': 'DEVICE', 'description': 'Single photon emission computed tomography (SPECT)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '250012', 'city': 'Jinan', 'state': 'Shandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'YUGUO CHEN', 'role': 'CONTACT'}], 'facility': 'Qilu Hospital of Shandong University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Jiaojiao Pang, Doctor', 'role': 'CONTACT', 'email': 'jiaojiaopang@126.com', 'phone': '0086-0531-82165398'}], 'overallOfficials': [{'name': 'Yuguo Chen, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Qliu Hospital of Shandong University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Hospital of Shandong University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Chongqing Emergency Medical Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}