Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-06-26 @ 4:56 AM
Study NCT ID:
NCT02768259
Status:
UNKNOWN
Last Update Posted:
2016-07-12
First Post:
2016-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevalence of Pulmonary Arterial Hypertension in Patients With Connective Tissue Diseases in Egyptian Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '1 Year', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-07-11', 'studyFirstSubmitDate': '2016-05-08', 'studyFirstSubmitQcDate': '2016-05-08', 'lastUpdatePostDateStruct': {'date': '2016-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence', 'timeFrame': '1 year', 'description': 'Pulmonary hypertension'}], 'secondaryOutcomes': [{'measure': 'Survival', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Connective Tissue Diseases', 'Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': '* Measuring the incidence and prevalence of PAH in Egyptian patients with different types of MCD\n* Determination of survival \\& the risk factors of mortality.', 'detailedDescription': "PH is defined as a mean pulmonary artery pressure greater than 25 mmHg. PAH can be assessed by different means, however right heart catheterization (RHC) is the gold standard diagnostic method .\n\nAmong the different subgroups of pulmonary arterial hypertension (PAH), those associated with connective tissue diseases (CTDs) are a specific entity with distinct hemodynamic and prognostic features reflecting the importance of a rheumatological assessment in PAH, especially with the unfavorable prognostic impact in these patients.\n\nCompared to patients with idiopathic PAH, patients with CTD-associated PAH have a higher mortality and a lower walking distance on the 6-minute walk test, higher levels of B-type natriuretic peptide, worse right ventricular function, more left-sided heart dysfunction, lower lung function, and more pericardial disease.\n\nThat's why, PAH screening is routinely performed in systemic sclerosis (SSc) and in other CTDs and also, as suggested by international guidelines, it is important to rule out CTDs in patients with PAH, because patients diagnosed as idiopathic PAH (iPAH) may have an associated CTD previously unrecognized.\n\nAlthough the similarities in pathogenesis of PAH in CTD such as systemic sclerosis (SSc), systemic lupus erythematosus (SLE), and mixed connective tissue disease (MCTD), there are variabilities in outcomes in patients with CTD-associated PAH."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed as connective tissue diseases fulfilling ACR criteria will be recruited', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients diagnosed as connective tissue diseases fulfilling ACR criteria will be recruited\n\nExclusion Criteria:\n\nnon\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02768259', 'briefTitle': 'Prevalence of Pulmonary Arterial Hypertension in Patients With Connective Tissue Diseases in Egyptian Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Prevalence of Pulmonary Arterial Hypertension in Patients With Connective Tissue in Egyptian Patients ( Single Center Study)', 'orgStudyIdInfo': {'id': 'Cairo2000'}}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa Elshazly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yusif Amin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Mervat Esam, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alshaima Rezk, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hebatallh Assal, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Amira AlmEldin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Hossam Rezk, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Reem Elkorashy, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Doaa H Attia', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kasr Alaini School of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mostafa I Elshazly, MD', 'role': 'CONTACT', 'email': 'elshazly66@hotmail.com', 'phone': '00201001272020'}], 'overallOfficials': [{'name': 'Mostafa I Elshazly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of pulmonary Medicine ,Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of pulmonary Medicine', 'investigatorFullName': 'Mostafa Elshazly', 'investigatorAffiliation': 'Cairo University'}}}}