Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT06659367
Status:
RECRUITING
Last Update Posted:
2024-10-26
First Post:
2024-10-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Dedinje FFR/QFR Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2034-10-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-24', 'studyFirstSubmitDate': '2024-10-23', 'studyFirstSubmitQcDate': '2024-10-24', 'lastUpdatePostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-10-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'correlation coefficient (r) between Quantitative Flow Ratio (QFR) and Fractional Flow Reserve (FFR)'}, {'measure': 'Sensitivity of Quantitative Flow Ratio (QFR)', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Sensitivity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard'}, {'measure': 'Specificity of Quantitative Flow Ratio (QFR)', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Specificity of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard'}, {'measure': 'Positive predictive value of Quantitative Flow Ratio (QFR)', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Positive predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard'}, {'measure': 'Negative predictive value of Quantitative Flow Ratio (QFR)', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Negative predictive value of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR) as the gold standard'}, {'measure': 'Diagnostic gray zone', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Quantitative Flow Ratio (QFR) limits for achieving 95% sensitivity and specificity in comparison to Fractional Flow Reserve (FFR)'}, {'measure': 'Diagnostic accuracy of Quantitative Flow Ratio (QFR) against Fractional Flow Reserve (FFR)', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Area under the curve (using cutoff values of \\<=0.80 for both methods)'}], 'secondaryOutcomes': [{'measure': 'Diagnostic performance of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Sensitivity, specificity, positive predictive value and negative predictive value of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR)'}, {'measure': 'Diagnostic accuracy of nonhyperemic pressure ratios and 3-dimensional Quantitative Coronary Angiography (3D-QCA) against Fractional Flow Reserve (FFR) as the gold standard', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Area under the curve (using cutoff values of \\<=0.89 for nonhyperemic pressure ratios and \\>=50% diameter stenosis for 3-dimensional Quantitative Coronary Angiography (3D-QCA)) against Fractional Flow Reserve (FFR, cutoff value \\<=0.80)'}, {'measure': 'Inter-observer variability', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Coefficient of variation for repeated Quantitative Flow Ratio (QFR) computation between users, standard deviation for repeated Quantitative Flow Ratio (QFR) measurements between users, binary diagnostic classification agreement between users'}, {'measure': 'Intra-observer variability', 'timeFrame': 'at the time of Quantitative Flow Ratio (QFR) analysis completion (up to 1 year)', 'description': 'Coefficient of variation for repeated Quantitative Flow Ratio (QFR) computation within users, standard deviation for repeated Quantitative Flow Ratio (QFR) measurements within users, binary diagnostic classification agreement within users'}, {'measure': 'All-cause death', 'timeFrame': 'at 6 months, 1 year and annually for 5 years', 'description': 'All-cause death'}, {'measure': 'Myocardial infarction', 'timeFrame': 'at 6 months, 1 year and annually for 5 years', 'description': 'Myocardial infarction'}, {'measure': 'Vessel-oriented composite outcome', 'timeFrame': 'at 6 months, 1 year and annually for 5 years', 'description': 'Cardiac death, vessel-related myocardial infarction and ischemia-driven target vessel revascularization'}, {'measure': 'Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months', 'timeFrame': '6 months', 'description': 'Change in Seattle Angina Questionnaire-7 Items Score (SAQ-7) at 6 months from the time of the Fractional Flow Reserve (FFR) procedure. (scale 0-100, 100 = full health, 0 = worst health)'}, {'measure': 'Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score', 'timeFrame': '6 months', 'description': 'Change in EuroQol-5 Dimensions- 5 Levels (EQ-5D-5L) Score at 6 months from the time of the Fractional Flow Reserve (FFR) procedure (scale 5-25, 5= no problems in any dimension, 25= extreme problems on all dimensions; visual analogue scale 0-100, 0= worst health possible, 100= best health possible)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['coronary artery disease', 'fractional flow reserve', 'quantitative flow ratio', 'FFR', 'QFR'], 'conditions': ['Coronary Artery Disease (CAD)', 'Fractional Flow Reserve']}, 'descriptionModule': {'briefSummary': 'Quantitative Flow Ratio (QFR) has shown good diagnostic performance against Fractional Flow Reserve (FFR) in several meta-analyses, comparable or even superior to nonhyperemic pressure ratios. However, the reproducibility of QFR is modest and there is high inter- and intra-observer variability even when fairly experienced but non-core lab operators (at least 150 QFR procedure experience) are performing the analysis. Although smaller studies have demonstrated that non-core analysis and even paramedical user analysis can have good correlation with FFR, the concern about the diagnostic performance of QFR in real-world clinical practice by inexperienced users remains.\n\nThe primary objective of "Dedinje FFR/QFR Registry" is to determine the feasibility and diagnostic performance of QFR analysis by vendor-certified inexperienced medical users in a real-world setting using FFR as the gold standard. All patients \\>18 years old who present to the Institute for Cardiovascular Diseases "Dedinje" and undergo a planned or ad hoc FFR procedure will be asked to participate in the registry. FFR procedure is performed according to the standardized institutional protocol. QFR analysis will be subsequently performed offline according to a standard operating procedure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients \\>18 years old who present to the Institute for Cardiovascular Diseases "Dedinje" and undergo a planned or ad hoc FFR procedure will be asked to participate in the registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\>18 years old\n* Had a clinically indicated FFR procedure performed (either as a planned procedure or ad hoc)\n\nExclusion Criteria:\n\n* Declines to participate in the registry and provide informed consent'}, 'identificationModule': {'nctId': 'NCT06659367', 'briefTitle': 'Dedinje FFR/QFR Registry', 'organization': {'class': 'OTHER', 'fullName': 'Institute for Cardiovascular Diseases Dedinje'}, 'officialTitle': 'Institute for Cardiovascular Diseases "Dedinje" Fractional Flow Reserve (FFR) and Quantitative Flow Ratio (QFR) Registry', 'orgStudyIdInfo': {'id': 'IRB4669'}}, 'contactsLocationsModule': {'locations': [{'zip': '11040', 'city': 'Belgrade', 'status': 'RECRUITING', 'country': 'Serbia', 'contacts': [{'name': 'Natalija Odanovic', 'role': 'CONTACT', 'email': 'natalija.odanovic@gmail.com', 'phone': '+381654732220'}, {'name': 'Natalija Odanovic, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Milan Dobric, MD, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ivan Ilic, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Institute for Cardiovascular Diseases "Dedinje"', 'geoPoint': {'lat': 44.80401, 'lon': 20.46513}}], 'centralContacts': [{'name': 'Natalija Odanovic, MD', 'role': 'CONTACT', 'email': 'natalija.odanovic@gmail.com', 'phone': '+381654732220'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD contains sensitive identifying patient information that patients are told will not be shared with anyone outside of the primary team of researchers.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institute for Cardiovascular Diseases Dedinje', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Natalija Odanovic', 'investigatorAffiliation': 'Institute for Cardiovascular Diseases Dedinje'}}}}