Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2025-12-30 @ 3:37 PM
Study NCT ID:
NCT06178133
Status:
UNKNOWN
Last Update Posted:
2023-12-20
First Post:
2023-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003327', 'term': 'Coronary Disease'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-12-11', 'lastUpdatePostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the discordance between fractional flow reserve and quantitative flow ratio', 'timeFrame': 'When the patient has completed coronary angiography and received a diagnosis', 'description': 'If FFR≤0.80 and QFR ≤0.8 or FFR \\> 0.80 and QFR \\> 0.8 are consistent groups, otherwise they are inconsistent group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Heart Disease']}, 'descriptionModule': {'briefSummary': 'In this study, patients were retrospectively included, univariate and multivariate analysis of factors affecting their diagnosis inconsistencies was performed, and a new diagnostic model was constructed by logistic regression.', 'detailedDescription': 'The evaluation of coronary function is becoming more and more important in the guidelines, in which coronary flow reserve (FFR) is the gold standard for diagnosis, but its measurement process requires the application of adenosine, vasodilator, etc. Some patients cannot be measured because of asthma and low blood pressure. A new instantaneous wave-free ratio (iFR), contrastive flow reserve fraction (cFFR) and quantitative flow fraction (QFR) have been developed for the evaluation of coronary function. However, in some patients, the new coronary function evaluation methods were inconsistent with FFR. In this study, patients were retrospectively included, univariate and multivariate analysis of factors affecting their diagnosis inconsistencies was performed, and a new diagnostic model was constructed by logistic regression.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who met the inclusion criteria and those who did not meet the exclusion criteria were admitted to the Department of Cardiovascular Medicine of Peking University Third Hospital from January 1, 2019 to November 31, 2023.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age above 18 and below 80 years old, regardless of gender;\n* FFR was detected by coronary angiography;\n* The coronary angiography images were clear, meeting the requirements of QFR analysis or detecting iFR, cFFR, and resting pd/pa during the operation.\n\nExclusion Criteria:\n\n* 1\\) Coronary artery bypass graft (CABG);\n* 2\\) Atrial fibrillation or flutter;\n* 3\\) Left or right coronary opening lesions;\n* 4\\) Pregnancy or breastfeeding.'}, 'identificationModule': {'nctId': 'NCT06178133', 'briefTitle': 'Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods', 'organization': {'class': 'OTHER', 'fullName': 'Peking University Third Hospital'}, 'officialTitle': 'Influencing Factors of the Diagnostic Accuracy of Novel Coronary Functional Evaluation Methods: a Cross-sectional Study', 'orgStudyIdInfo': {'id': 'M2023683'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'FFR', 'description': 'In this single-center cross-sectional study, we included patients with non-acute myocardial infarction who were admitted to the Department of Cardiology at Peking University Third Hospital for FFR testing from January 2019 to December 2021.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Ruitao Zhang', 'role': 'CONTACT', 'email': 'clinicboy@126.com', 'phone': '13001203879'}, {'name': 'Pengxin Xie', 'role': 'CONTACT', 'email': 'xiepengxin2014@163.com', 'phone': '18810793282'}], 'overallOfficials': [{'name': 'Ruitao Zhang', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University Third Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University Third Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}