Ignite Creation Date:
2025-12-24 @ 12:49 PM
Ignite Modification Date:
2025-12-28 @ 7:45 PM
Study NCT ID:
NCT05197361
Status:
UNKNOWN
Last Update Posted:
2022-03-03
First Post:
2022-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007511', 'term': 'Ischemia'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D053805', 'term': 'Fractional Flow Reserve, Myocardial'}], 'ancestors': [{'id': 'D003326', 'term': 'Coronary Circulation'}, {'id': 'D001775', 'term': 'Blood Circulation'}, {'id': 'D002320', 'term': 'Cardiovascular Physiological Phenomena'}, {'id': 'D002943', 'term': 'Circulatory and Respiratory Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-02', 'studyFirstSubmitDate': '2022-01-05', 'studyFirstSubmitQcDate': '2022-01-05', 'lastUpdatePostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Variation in the values of IMR between basal and 6-months follow-up', 'timeFrame': '6 months'}, {'measure': 'Variation in the values of absolute coronary flow between basal and 6-months follow-up', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Total Occlusion of Coronary Artery', 'Microvascular Coronary Artery Disease', 'Coronary; Ischemic', 'Coronary Microvascular Dysfunction']}, 'descriptionModule': {'briefSummary': 'It is an observational study which objective is to analyze, through a series of invasive parameters, the state of the coronary microvasculature immediately after the successful percutaneous coronary intervention of a chronic total occlusion and at 6 months after the index procedure.\n\nThe aim of the study is to check the variation in the values of the index of microcirculatory resistance (IMR) and invasive absolute coronary flow (AF). The working hypothesis is that, in the follow-up of these patients, AF will increase significantly with respect to its baseline and, conversely, IMR will be reduced during the follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with ischemic heart disease and evidence of at least one chronic total occlusion, with data of inducible ischemia and/or viability and susceptible to percutaneous coronary intervention.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Those patients with a clinical indication for percutaneous coronary intervention of a chronic total occlusion. As a routine clinical practice in our center, it is proposed to perform a angiographic follow-up 6 months after the index procedure.\n\nExclusion Criteria:\n\n* No specific exclusion criteria.'}, 'identificationModule': {'nctId': 'NCT05197361', 'acronym': 'FLOW-CTO', 'briefTitle': 'Microvascular Coronary Resistance and Absolute Coronary FLOW in Patients With Percutaneous Intervention of a Chronic Total Occlusion', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'Evolución de Las Resistencias Microvasculares y Del Flujo Coronario Absoluto en Pacientes Con intervención Coronaria percutánea de Una oclusión crónica', 'orgStudyIdInfo': {'id': 'FLOW1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Global cohort', 'description': 'Invasive coronary physiology parameters estimation, including:\n\nFFR, CFR, IMR, Absolute coronary flow (AF). AF derived resistances', 'interventionNames': ['Diagnostic Test: Invasive coronary physiology']}], 'interventions': [{'name': 'Invasive coronary physiology', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['fractional flow reserve', 'coronary flow reserve', 'index of microvascular resistance', 'absolute coronary flow', 'AF-derived coronary resistance'], 'description': 'Estimation of guide-wire coronary physiology parameters', 'armGroupLabels': ['Global cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital Universitari de Bellvitge', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Cadiz', 'country': 'Spain', 'facility': 'Hospital Puerta del Mar', 'geoPoint': {'lat': 36.52672, 'lon': -6.2891}}, {'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario de La Princesa', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}