Ignite Creation Date:
2025-12-26 @ 10:58 AM
Ignite Modification Date:
2025-12-31 @ 1:27 PM
Study NCT ID:
NCT01135706
Status:
COMPLETED
Last Update Posted:
2012-11-01
First Post:
2010-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-31', 'studyFirstSubmitDate': '2010-05-20', 'studyFirstSubmitQcDate': '2010-06-02', 'lastUpdatePostDateStruct': {'date': '2012-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FD of the pulmonary artery in patients with PH will be lower when compared to patients without PH.', 'timeFrame': '24 Months'}], 'secondaryOutcomes': [{'measure': 'FD will correlate with the degree of PH as quantified by the MPAP obtained during RHC.', 'timeFrame': '24 Months'}, {'measure': 'FD will correlate with the functional capacity of the PH patients as quantified by distance during six-minute walk and NYHA functional class.', 'timeFrame': '24 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Fractal dimension'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The investigators propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.', 'detailedDescription': 'Pulmonary hypertension (PH) is an insidious disorder that can occur in isolation or as a result of various other pulmonary and systemic conditions. If left untreated PH may progress to right heart failure and death. Numerous tests are suggestive but not diagnostic of PH including cardiac echo, pulmonary function testing and chest x-ray. Definitive diagnosis requires right heart catheterization that is invasive, costly and time consuming. The fractal dimension (FD) is an index of the space-filling properties of an object so that the closer the dimension is to the topological dimension in which the object is embedded, the greater the space filling properties. No investigations have been performed to analyze the fractal dimension of pulmonary arteries in patients with PH. We propose to confirm that normotensive and hypertensive pulmonary arteries are fractal, as well as define if the FD correlates to disease severity when compared to available data such as six-minute walk and right heart catheterization measurements.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients having a right heart catheterization and CT pulmonary angiogram', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients having a right heart catheterization and CT pulmonary angiogram\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT01135706', 'briefTitle': 'Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University'}, 'officialTitle': 'Fractal Analysis of the Pulmonary Arterial Tree in Pulmonary Hypertension.', 'orgStudyIdInfo': {'id': '2010H0097'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pulmonary Hypertension', 'description': 'Patients having a right heart catheterization and CT pulmonary angiogram with a diagnosis of Pulmonary Hypertension', 'interventionNames': ['Other: No Intervention']}, {'label': 'Non Pulmonary Hypertension', 'description': 'Patients having a right heart catheterization and CT pulmonary angiogram without a diagnosis of Pulmonary Hypertension.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'description': 'This study does not include an intervention but is observational in nature.', 'armGroupLabels': ['Non Pulmonary Hypertension', 'Pulmonary Hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'overallOfficials': [{'name': 'Karen Wood, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Karen Wood', 'investigatorAffiliation': 'Ohio State University'}}}}