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Study of Bronchiectasis and Associated Cardiovascular Comorbidities

Sponsor
Assiut University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05783869
Collaborator
Aliae AR Mohamed Hussein [ahussein (Other)
30
Enrollment
1
Location
7.3
Anticipated Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Effect of cardiovascular comorbidities on disease severity and quality of life in Patients with acute exacerbation of non-cystic fibrosis bronchiectasis

Condition or Disease Intervention/Treatment Phase
  • Device: Echocardiography

Detailed Description

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Official Title:
Effect of Cardiovascular Comorbidities on Disease Severity and Quality of Life in Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis
Actual Study Start Date :
Mar 25, 2023
Anticipated Primary Completion Date :
Sep 1, 2023
Anticipated Study Completion Date :
Nov 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Patient with bronchiectasis and cardiovascular comorbidities

Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.

Device: Echocardiography
echocardiographic study of both groups
Other Names:
  • Pulmonary function test
  • Routine laboratory investigations and inflammatory markers

    		•
    Patients with bronchiectasis and without cardiovascular comorbidities

    Patients with Bronchiectasis had no comorbidities.

    Device: Echocardiography
    echocardiographic study of both groups
    Other Names:
  • Pulmonary function test
  • Routine laboratory investigations and inflammatory markers

    		•

    Outcome Measures

    Primary Outcome Measures

    1. assessment of BNP (Brain natriuretic peptide) pg/ml levels in patients with bronchiectasis and cardiovascular comorbidities. [March 2023 to September 2023]

      Serum BNP (Brain natriuretic peptide) pg/ml will be compared in both groups.

    2. Assessment of Quality of life in patients and control groups using The Short Form (36) Health Survey (SF-36) [March 2023 to September 2023]

      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.

    Secondary Outcome Measures

    1. Hospitalization frequency in patient group compared to control group. [March 2023 to September 2023]

      Number of hospital admission in the last year will be compared in both groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Any Patients with Bronchiectasis had no comorbidities other than cardiovascular comorbidities during the study period.

    Exclusion Criteria:

    • Any Patients who refuse to participate in the study.

    • Any other comorbidity or end-organ failure may affect the study's result.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Assiut unviresty - Faculty of Medicine Assiut Egypt 71511

    Sponsors and Collaborators

    • Assiut University
    • Aliae AR Mohamed Hussein [ahussein

    Investigators

    • Principal Investigator: Ahmad Shaddad, Assuit University Faculty of Medicine
    • Principal Investigator: Ahmad Shaddad, Assiut University Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmad Shaddad, Lecturer of pulmonary medicine Assuit university, Assiut University
    ClinicalTrials.gov Identifier:
    NCT05783869
    Other Study ID Numbers:
    • 23455668
    First Posted:
    Mar 24, 2023
    Last Update Posted:
    Mar 28, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Bronchiectasis

    Study Results

    No Results Posted as of Mar 28, 2023