Ignite Creation Date:
2025-12-26 @ 12:14 PM
Ignite Modification Date:
2025-12-31 @ 1:43 PM
Study NCT ID:
NCT03824600
Status:
COMPLETED
Last Update Posted:
2020-03-30
First Post:
2019-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiological Patterns of Coronary Artery Disease
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': 'ACTUAL', 'count': 117}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-27', 'studyFirstSubmitDate': '2019-01-27', 'studyFirstSubmitQcDate': '2019-01-30', 'lastUpdatePostDateStruct': {'date': '2020-03-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Classification of the physiological patterns of coronary artery disease using a quantitative metric', 'timeFrame': 'Immediate post-procedure. No follow-up is schedule for this trial.', 'description': 'Based on the data obtained using the fractional flow reserve pullbacks and conventional coronary angiography a quantitative classification of the physiological pattern of coronary artery disease based on the functional contribution of the epicardial lesion (i.e. lesion-related pressure drop) with respect to the total vessel fractional flow reserve will be explored.'}], 'primaryOutcomes': [{'measure': 'Physiological Patterns of Coronary Artery Disease (i.e. focal, diffuse or combined)', 'timeFrame': 'Immediate post-procedure. No follow-up is schedule for this trial.', 'description': 'Describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease. A pullback device adapted to grip the coronary pressure wire with a speed of 1 mm/sec during continued pressure recording will be used. A fractional flow reserve value every 100 microns will be extracted from the pressure tracing and plotted against the length to generate a pullback curve. Fractional flow reserve will be defined as the ratio of the moving average of the proximal and distal coronary pressures. The patterns of physiological disease will be classified as focal or diffuse according to the visual inspection of the fractional flow reserve pullback curve. The patterns of coronary artery disease will be reported as a focal, diffuse or combined pattern (i.e. focal and diffuse).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '33778020', 'type': 'DERIVED', 'citation': 'Argacha JF, Decamp J, Vandeloo B, Babin D, Lochy S, Van den Bussche K, de Hemptinne Q, Xaplanteris P, Magne J, Segers P, Cosyns B. Guiding Myocardial Revascularization by Algorithmic Interpretation of FFR Pullback Curves: A Proof of Concept Study. Front Cardiovasc Med. 2021 Mar 11;8:623841. doi: 10.3389/fcvm.2021.623841. eCollection 2021.'}, {'pmid': '31582137', 'type': 'DERIVED', 'citation': "Collet C, Sonck J, Vandeloo B, Mizukami T, Roosens B, Lochy S, Argacha JF, Schoors D, Colaiori I, Di Gioia G, Kodeboina M, Suzuki H, Van 't Veer M, Bartunek J, Barbato E, Cosyns B, De Bruyne B. Measurement of Hyperemic Pullback Pressure Gradients to Characterize Patterns of Coronary Atherosclerosis. J Am Coll Cardiol. 2019 Oct 8;74(14):1772-1784. doi: 10.1016/j.jacc.2019.07.072."}]}, 'descriptionModule': {'briefSummary': 'Registry of patients undergoing invasive fractional flow reserve measurement using a motorized device.', 'detailedDescription': 'A prospective registry of patients undergoing clinically indicated coronary angiography with fractional flow reserve evaluation for vessels with intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%. A motorized fractional flow reservepullback evaluation will be performed at the discretion of the operators. The objective of the present study is to describe the physiological patterns of coronary artery disease using motorized coronary pressure pullbacks during continuous hyperemia in patients with stable coronary artery disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing clinically indicated coronary angiography and fractional flow reserve evaluation for intermediate coronary lesions defined as visual diameter stenosis between 30% and 70%', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable coronary artery disease\n\nExclusion Criteria:\n\n* acute coronary syndromes\n* previous coronary artery bypass grafting\n* significant valvular disease\n* severe obstructive pulmonary disease or asthma bronchial\n* severe tortuosity or severe calcification'}, 'identificationModule': {'nctId': 'NCT03824600', 'briefTitle': 'Physiological Patterns of Coronary Artery Disease', 'organization': {'class': 'OTHER', 'fullName': 'Onze Lieve Vrouw Hospital'}, 'officialTitle': 'Physiological Patterns of Coronary Artery Disease', 'orgStudyIdInfo': {'id': 'CRI-0002'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Fractional Flow Reserve Motorized Pullback', 'type': 'DIAGNOSTIC_TEST', 'description': 'A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '9300', 'city': 'Aalst', 'state': 'West Flanders', 'country': 'Belgium', 'facility': 'OLV Aalst', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'University of Brussels', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'overallOfficials': [{'name': 'Bernard De Bruyne, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'OLV-Aalst'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Onze Lieve Vrouw Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Co-Director Catheterization Laboratory', 'investigatorFullName': 'Jeroen Sonck', 'investigatorAffiliation': 'Onze Lieve Vrouw Hospital'}}}}