Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-03-01 @ 9:32 AM
Study NCT ID:
NCT03396120
Status:
COMPLETED
Last Update Posted:
2018-01-10
First Post:
2018-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012129', 'term': 'Respiratory Function Tests'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-05', 'studyFirstSubmitDate': '2018-01-05', 'studyFirstSubmitQcDate': '2018-01-05', 'lastUpdatePostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'value of FVC/DLCO in predicting PAH in IPF', 'timeFrame': '6 months', 'description': 'To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Interstitial Lung Disease', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Pulmonary hypertension (PH) is a common disorder among patients with interstitial lung disease (ILD). The symptoms are usually nonspecific and overlooked. Thus, a noninvasive screening modality is recommended for early detection of PH because of its potentially significant impact on treatment strategy and clinical outcomes.\n\nObjectives: To evaluate the usefulness of assessing forced vital capacity (FVC%), diffusion capacity of the lung for carbon monoxide (DLCO%), and FVC%/DLCO% ratio to predict pulmonary hypertension among patients with ILDs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '\\- ILD was diagnosed on the basis of clinical, radiological and functional assessments', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* This retrospective study included all patients diagnosed with interstitial lung disease (ILD) who were followed up by the chest department of a tertiary hospital between September 2016 and January 2017\n\nExclusion Criteria:\n\n* patients with occupational history\n* collagen vascular disease predisposing them to lung disorders\n* patients who could not undergo pulmonary function testing'}, 'identificationModule': {'nctId': 'NCT03396120', 'briefTitle': 'The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'The FVC/DLCO Ratio is a Useful Predictor of Pulmonary Hypertension in Patients With Interstitial Lung Disease', 'orgStudyIdInfo': {'id': 'AssiutU6'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Pulmonary function test', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['FVC/DLCO'], 'description': 'forced vital capacity and diffusing capacity'}]}, 'contactsLocationsModule': {'locations': [{'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'AssiutU', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}, {'zip': '71111', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Pulmonology Departments', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pulmonology', 'investigatorFullName': 'Aliae AR Mohamed Hussein', 'investigatorAffiliation': 'Assiut University'}}}}