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Completed
NCT07809399
Volumetric HRCT in Stable COPD Patients.
Conditions: Chronic Obstructive Pulmonary Disease, Pulmonary Emphysema, Airway Obstruction
Sex: All
Ages: 18 Years – N/A
Enrollment: 75
Sponsor: Mansoura University
Location: Mansoura University Hospital (Chest Disease Department) Al Mansurah Dakahlia Governorate
Summary
This study evaluates the role of volumetric high-resolution computed tomography (HRCT) of the chest in assessing patients with stable chronic obstructive pulmonary disease (COPD). COPD is a heterogeneous lung condition characterized by chronic pulmonary symptoms, structural airway/alveolar changes, and progressive airflow limitation. While spirometry provides a global assessment of lung function, it cannot localize or fully characterize specific structural abnormalities. Volumetric HRCT allows for detailed, quantitative imaging of lung parenchyma, emphysema extent, air trapping, and airway wall thickness. The primary objective of this cross-sectional observational study is to quantify emphysema, air trapping, and bronchial wall thickness in patients with stable COPD and to evaluate the relationship between these volumetric HRCT findings and clinical measures of disease severity. By identifying objective imaging parameters, this study aims to improve patient evaluation, disease staging, and clinical management.
Eligibility Criteria
Inclusion Criteria:Patients with stable chronic obstructive pulmonary disease (COPD)
Diagnosed according to GOLD criteria (post-bronchodilator FEV1/FVC \< 0.70)
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Exclusion Criteria:
1. Patient in exacerbation defined as change in the patient's baseline dyspnea, cough, and/or sputum beyond normal day-to-day variations within 14 days . (Ko, Fanny W., et al 2016)
2. Connective tissue disease .
3. Previously diagnosed Interstitial lung disease
4. Contraindication to PFT According to ATS (Stanojevic S., et al 2021)
* Recent Myocardial Infarction Within 1 week
* Blood Pressure Instability Severe hypertension or systemic hypotension
* Arrhythmias Significant, uncontrolled atrial or ventricular arrhythmias
* Decompensated heart failure
* Pulmonary Circulation Issues: Uncontrolled pulmonary hypertension, acute cor pulmonale, or clinically unstable pulmonary embolism
* History of Syncope Loss of consciousness related to coughing or forced expiration
* Cerebral Aneurysm
* Recent Brain Surgery: Within 4 weeks
* Concussion: Recent concussion with prolonged symptoms
* Eye Surgery: Recent eye surgery within 1 week
* Pneumothorax: Active or untreated pneumothorax Recent Thoracic Surgery: Within 4 weeks Recent Abdominal Surgery: Within 4 weeks Late-Term Pregnancy
5. Contraindicatins of 6MWT according to ATS :
Absolute contraindications
* Unstable Angina Experienced during the previous 1 month.
* Recent Myocardial Infarction : Within the previous 1 month. Relative contraindications
* Resting Tachycardia: Resting heart rate \> 120{ bpm}.
* Severe Uncontrolled Hypertension:
* Systolic Blood Pressure \> 180{ mmHg}
* Diastolic Blood Pressure \> 100{ mmHg}
* Symptomatic/Severe Cardiac Conditions: High-degree atrioventricular (AV) block, hypertrophic cardiomyopathy, or symptomatic severe aortic stenosis.
Source: ClinicalTrials.gov (NCT07809399). StuddyBuddy aggregates publicly available trial information.