Study of Bronchiectasis and Associated Cardiovascular Comorbidities

Effect of Cardiovascular Comorbidities on Disease Severity and Quality of Life in Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis

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

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Ahmad Shaddad, MD; Phone Number: +201111171930; Email: shaddad_ahmad@yahoo.com
• Study Contact Backup: Name: Shaadad Shaddad, MD; Phone Number: +201111171930; Email: shaddad_ahmad@yahoo.com

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Recruiting
    • Assiut unviresty - Faculty of Medicine
    • Contact: Ahmad Shaddad, Lecturer; Phone Number: +201111171930; Email: shaddad_ahmad@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

all patients at the study period attending the chest department at Assuit university

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assessment of BNP (Brain natriuretic peptide) pg/ml levels in patients with bronchiectasis and cardiovascular comorbidities.	Serum BNP (Brain natriuretic peptide) pg/ml will be compared in both groups.	March 2023 to September 2023
Assessment of Quality of life in patients and control groups using The Short Form (36) Health Survey (SF-36)	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.	March 2023 to September 2023

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalization frequency in patient group compared to control group.	Number of hospital admission in the last year will be compared in both groups.	March 2023 to September 2023

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: 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 record dates

Study Major Dates

• Study Start (Actual): March 25, 2023
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): November 1, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: March 23, 2023
• First Posted (Actual): March 24, 2023

Study Record Updates

• Last Update Posted (Actual): March 28, 2023
• Last Update Submitted That Met QC Criteria: March 26, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: 23455668

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No