Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT05783869
Status:
RECRUITING
Last Update Posted:
2025-05-11
First Post:
2023-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Bronchiectasis and Associated Cardiovascular Comorbidities
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001987', 'term': 'Bronchiectasis'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2023-02-12', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2025-05-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assessment of BNP (Brain natriuretic peptide) pg/ml levels in patients with bronchiectasis and cardiovascular comorbidities.', 'timeFrame': 'March 2023 to September 2023', 'description': 'Serum BNP (Brain natriuretic peptide) pg/ml will be compared in both groups.'}, {'measure': 'Assessment of Quality of life in patients and control groups using The Short Form (36) Health Survey (SF-36)', 'timeFrame': 'March 2023 to September 2023', 'description': 'The Short Form (36) Health Survey will be performed in both groups. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.'}], 'secondaryOutcomes': [{'measure': 'Hospitalization frequency in patient group compared to control group.', 'timeFrame': 'March 2023 to September 2023', 'description': 'Number of hospital admission in the last year will be compared in both groups.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchiectasis']}, 'descriptionModule': {'briefSummary': 'Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis', 'detailedDescription': 'The study will include patients with bronchiectasis, and in an attempt to correlate the effect and burden of cardiovascular comorbidities in those patients, we will study the quality of life in those patients in comparison to the control group ( patients with bronchiectasis and without any other comorbidities) using SF-36 quality of life questionnaire. We will also study the inflammatory markers in both groups using D-dimer, BNP, and CRP and correlate them with the frequency of hospital admission, the severity of symptoms, and the general health state.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'all patients at the study period attending the chest department at Assuit university', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n• Any Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.\n\nExclusion Criteria:\n\n* Any Patients who refuse to participate in the study.\n* Any other comorbidity or end-organ failure may affect the study's result."}, 'identificationModule': {'nctId': 'NCT05783869', 'briefTitle': 'Study of Bronchiectasis and Associated Cardiovascular Comorbidities', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Cardiovascular Comorbidities on Disease Severity and Quality of Life in Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis', 'orgStudyIdInfo': {'id': '23455668'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient with bronchiectasis and cardiovascular comorbidities', 'description': 'Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.', 'interventionNames': ['Device: Echocardiography']}, {'label': 'Patients with bronchiectasis and without cardiovascular comorbidities', 'description': 'Patients with Bronchiectasis had no comorbidities.', 'interventionNames': ['Device: Echocardiography']}], 'interventions': [{'name': 'Echocardiography', 'type': 'DEVICE', 'otherNames': ['Pulmonary function test', 'Routine laboratory investigations and inflammatory markers'], 'description': 'echocardiographic study of both groups', 'armGroupLabels': ['Patient with bronchiectasis and cardiovascular comorbidities', 'Patients with bronchiectasis and without cardiovascular comorbidities']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ahmad Shaddad, Lecturer', 'role': 'CONTACT', 'email': 'shaddad_ahmad@yahoo.com', 'phone': '+201111171930'}], 'facility': 'Assiut unviresty - Faculty of Medicine', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'Shaadad Shaddad, MD', 'role': 'CONTACT', 'email': 'shaddad_ahmad@yahoo.com', 'phone': '+201111171930'}, {'name': 'Ahmad Shaddad, MD', 'role': 'CONTACT', 'email': 'shaddad_ahmad@yahoo.com', 'phone': '+201111171930'}], 'overallOfficials': [{'name': 'Ahmad Shaddad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assuit University Faculty of Medicine'}, {'name': 'Ahmad Shaddad', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assiut University Faculty of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aliae AR Mohamed Hussein [ahussein', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of pulmonary medicine Assuit university', 'investigatorFullName': 'Ahmad Shaddad', 'investigatorAffiliation': 'Assiut University'}}}}