Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2026-01-01 @ 8:03 AM
Study NCT ID:
NCT04554004
Status:
COMPLETED
Last Update Posted:
2025-06-04
First Post:
2020-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Non-invasive Index of Microciculatory Resistance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017566', 'term': 'Microvascular Angina'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 295}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-01', 'studyFirstSubmitDate': '2020-09-08', 'studyFirstSubmitQcDate': '2020-09-12', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sensitivity and specificity', 'timeFrame': 'up to 12 months', 'description': 'The sensitivity and specificity of CT-IMR in the diagnosis of microcirculation dysfunction were studied.'}], 'secondaryOutcomes': [{'measure': 'diagnostic', 'timeFrame': 'up to 12 months', 'description': 'To study the diagnostic coincidence rate, positive predictive value and negative predictive value of CT-IMR in the diagnosis of microcirculation dysfunction.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Microvascular Disease', 'Coronary Artery Disease']}, 'descriptionModule': {'briefSummary': 'Coronary artery microvascular disease (CMVD) lacks reliable and non-invasive quantitative diagnosis methods. Improving coronary microcirculation has become one of the main goals of coronary heart disease treatment. In this study, by establishing the key influencing factors of myocardial microcirculation perfusion, an accurate three-dimensional reconstruction method of coronary artery was established, and a non-invasive coronary microcirculation resistance index (CT-IMR) calculation method based on computational fluid method mechanics was established. At the same time, a phase I single-center clinical verification and a multi-center clinical verification of the non-invasive coronary microcirculation function precision assessment system were carried out, and a non-invasive coronary microcirculation detection system and technology were established.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject must be older than 18 years\n* Written informed consent available\n* Subject is indicated for invasive coronary angiography\n* Subject need to be taken within 30 days after enrolment\n\nExclusion Criteria:\n\n* Previous PCI or CABG\n* Subject is not eligible for measuring IMR\n* Complicated complex congenital heart disease\n* Artificial pacemaker or internal defibrillator leads implanted\n* Implanted artificial heart valve\n* Severe arrhythmia including complete AV block, ventricular arrhythmia\n* Impaired chronic renal function (serum creatinine\\>1.5ULN)\n* Allergic to iodine\n* Pregnancy\n* Body mass index \\>35 kg/m2\n* Left ventricle is markedly thickened\n* Needs for emergency procedures\n* Severe distortion of in the blood vessel\n* Unstable haemodynamics including abrupt chest pain cardiogenic shock, unstable blood pressure (systolic \\< 90mmHg), severe congestive heart failure or pulmonary edema\n* Life-threatening diseases (life expectancy \\< 2 months)\n* Tako Tsubo syndrome (TTS)\n* Others who are inappropriate subject judged by clinician'}, 'identificationModule': {'nctId': 'NCT04554004', 'briefTitle': 'A Non-invasive Index of Microciculatory Resistance', 'organization': {'class': 'OTHER', 'fullName': "First People's Hospital of Hangzhou"}, 'officialTitle': 'A Clinical Trial for CT Myocardial Perfusion Based Non-invasive Index of Microciculatory Resistance', 'orgStudyIdInfo': {'id': '2020C03018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'All consecutive patients undergoing outine CT angiography and dynamic CT-myocardial perfusion imaging(MPI) will be potentially eligible for inclusion in the trial. Assessment of coronary stenosis severity using invasive fractional flow reserve (FFR) and the status of myocardial microcirculation perfusion including coronary flow reserve (CFR) and index of microvascular resistance (IMR) will be performed as part of invasive coronary angiography(CAG).', 'interventionNames': ['Diagnostic Test: CCTA, CT-MPI, DSA, FFR']}], 'interventions': [{'name': 'CCTA, CT-MPI, DSA, FFR', 'type': 'DIAGNOSTIC_TEST', 'description': 'The patients who enrolled the study will undergo coronary CT angiography(CCTA), dynamic CT-MPI, invasive coronary angiography and invasive computation of fractional flow reserve (FFR)', 'armGroupLabels': ['Study group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hanzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "First People's Hospital of Hangzhou"}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'ICF'], 'timeFrame': 'When will data be available (start and end dates)?Beginning 3 months. No end data.', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article after deidentification (text, table, figures, and appendices).', 'accessCriteria': 'Proposals should be directed to zdsyhjy0902@zju.edu.cn. To gain access, data requestors will need to sign a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "First People's Hospital of Hangzhou", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Jinyu Huang', 'investigatorAffiliation': "First People's Hospital of Hangzhou"}}}}