Ignite Creation Date:
2025-12-24 @ 5:16 PM
Ignite Modification Date:
2025-12-28 @ 4:14 AM
Study NCT ID:
NCT04494750
Status:
UNKNOWN
Last Update Posted:
2022-01-31
First Post:
2020-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Physiology and Residual Ischemia After Percutaneous Coronary Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D023903', 'term': 'Coronary Restenosis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D023921', 'term': 'Coronary Stenosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 260}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-01-28', 'studyFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2020-07-30', 'lastUpdatePostDateStruct': {'date': '2022-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of successful uncomplicated PCI as per coronary physiology ratios', 'timeFrame': 'Transprocedural, initial and final values', 'description': 'Record the minimal values reported for Pd/Pa, dPR and FFR ratios in the distal vessel after uncomplicated PCI and good angiographic result.Comparison between baseline (pre PCI) and final (post PCI) coronary physiology ratios .'}], 'secondaryOutcomes': [{'measure': 'Incidence and types of further interventions or imaging techniques', 'timeFrame': 'Historical and immediately after the procedure, up to 36 months', 'description': 'Record the incidence by type of intervention and diagnostic or imaging techniques'}, {'measure': 'Residual symptoms and quality of life after repeat angiography', 'timeFrame': 'up to 30 days', 'description': 'Identify residual symptoms after intervention, and overall immediate quality of life.'}, {'measure': 'Rates of repeat interventions', 'timeFrame': 'Historical and immediately after the procedure', 'description': 'on previously intervened lesions versus PCI on new lesions'}, {'measure': 'Incidence of successful distal positioning of pressurewire', 'timeFrame': 'Transprocedural'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Coronary Artery Disease', 'Fractional Flow Reserve (FFR)', 'Coronary physiology', 'Repeat intervention', 'diastolic pressure ratio (dPR)'], 'conditions': ['Ischemic Heart Disease', 'Angina Pectoris', 'Chest Pain', 'Coronary Artery Disease', 'Coronary Restenosis']}, 'descriptionModule': {'briefSummary': 'Despite optimal angiographic result after stent implantation, a number of patients will undergo repeat angiography within 1 year of index procedure. EASY-PRIPCI is an observational study evaluating the incidence of abnormal physiology results in patients undergoing repeat angiography after uncomplicated percutaneous intervention (PCI).', 'detailedDescription': 'Despite successful PCI and complete revascularization, about 25% of patients will present with angina and/or positive exercise testing during follow-up. With recurring or persistent symptoms, a number of those patients will be referred for control angiography. This might create a significant burden for health systems as well as putting patients to undergo further interventions without clear demonstration of ischemia.\n\nAssessing physiology and fractional flow reserve in particular after PCI could represent a further step to determine whether stent implantation and stenosis removal will be effective to relieve subjective and objective signs of ischemia.\n\nHypothesis:\n\nResting gradients such as whole cycle Pd/Pa and diastolic dPR and FFR will be abnormal (below ischemic threshold) in \\> 20% of cases despite optimal stent implantation and angiographic result.\n\nThe use of physiology assessment in previously intervened vessels in patients referred for persisting or recurring angina might help operators to decide upon further intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients returning to the Quebec Heart Institute for a diagnostic angiography and possible PCI within 12 months of a previous uncomplicated PCI with stent implantation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Any patient referred for diagnostic angiography and possible PCI within 12 months of uncomplicated PCI with stent implantation.\n\nExclusion Criteria:\n\n* Unable to understand study design or objectives of study.\n* Unable to sign informed consent.\n* Evidence of in-stent restenosis or significant untreated coronary lesions (initial incomplete revascularization)\n* Inability to comply with the study follow-up'}, 'identificationModule': {'nctId': 'NCT04494750', 'acronym': 'EASY-PRIPCI', 'briefTitle': 'Physiology and Residual Ischemia After Percutaneous Coronary Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Physiology and Residual Ischemia After Percutaneous Coronary Intervention (EArly Discharge After Transradial Stenting of CoronarY Arteries- EASY- PRIPCI)', 'orgStudyIdInfo': {'id': 'EASY-PRIPCI'}}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 4G5', 'city': 'Québec', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Olivier F Bertrand, MD PhD', 'role': 'CONTACT', 'email': 'olivier.bertrand@crhl.ulaval.ca', 'phone': '418 656 8711'}, {'name': 'Olivier F Bertrand, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Tomas Cieza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IUCPQ - Laval Hospital', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'centralContacts': [{'name': 'Olivier F. Bertrand, MD, PhD', 'role': 'CONTACT', 'email': 'olivier.bertrand@chul.ulaval.ca', 'phone': '+14186568711', 'phoneExt': '5947'}], 'overallOfficials': [{'name': 'Olivier F. Bertrand, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Quebec Heart Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the International Chair of Interventional Cardiology and Transradial Approach', 'investigatorFullName': 'Olivier F. Bertrand', 'investigatorAffiliation': 'Laval University'}}}}