Volumetric HRCT in Stable COPD Patients.
The Role of Volumetric High-Resolution Computed Tomography (HRCT) of the Chest in the Assessment of Patients With Stable Chronic Obstructive Pulmonary Disease (COPD)
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
상세 설명
Background and Rationale:
Chronic Obstructive Pulmonary Disease (COPD) is characterized by persistent respiratory symptoms (such as dyspnea, cough, and sputum production) resulting from airway and/or alveolar abnormalities that cause progressive airflow obstruction. While irreversible airflow obstruction (post-bronchodilator FEV1/FVC < 0.70) measured by spirometry confirms the diagnosis, global spirometric tests lack the spatial resolution required to assess regional parenchymal destruction, emphysema distribution, or peripheral air trapping. Volumetric High-Resolution Computed Tomography (HRCT) enables detailed, three-dimensional quantitative assessment of lung parenchyma and structural alterations in COPD.
Study Objectives:
To quantify emphysema extent, air trapping, and airway wall thickness using volumetric HRCT.
To assess the relationship between quantitative volumetric HRCT findings and clinical measures of COPD severity.
Methods and Procedures:
This cross-sectional observational study is conducted at Mansoura University Hospital (smoking clinic and chest disease general clinic) under ethics approval code MS.25.02.3101. Enrolled participants include patients with stable COPD diagnosed according to GOLD guidelines.
All participants undergo the following assessments:
Clinical Evaluation: Comprehensive history taking (symptoms, smoking status), physical examination, and mMRC Dyspnea Scale grading.
Pulmonary Function Testing & Lung Volumes: Spirometry (FEV1, FVC, FEV1/FVC, MMEF), 6-Minute Walk Test (6MWT), and lung volume measurements (RV, TLC, RV/TLC%).
Laboratory Tests: Complete Blood Count (CBC) with calculation of Neutrophil-to-Lymphocyte Ratio (NLR) and Platelet-to-Lymphocyte Ratio (PLR), and Arterial Blood Gas (ABG) analysis.
HRCT Imaging Protocol: Multidetector HRCT (minimum 64-slice, ≤1,5 mm slice thickness, 512x512 matrix) performed during full inspiratory breath-hold (with optional expiratory scanning for air trapping evaluation). Dedicated high-resolution algorithms and window settings are applied to quantify parenchymal and bronchial changes.
nd bronchial changes.
연구 유형
연구 유형
등록 (실제)
등록
연락처 및 위치
연구 장소
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, 이집트, 35516
- Mansoura University Hospital (Chest Disease Department)
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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:
- 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)
- Connective tissue disease .
- Previously diagnosed Interstitial lung disease
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
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
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Stable COPD Patients
Stable Chronic Obstructive Pulmonary Disease (COPD) patients undergoing quantitative volumetric High-Resolution Computed Tomography (HRCT) of the chest to evaluate parameters such as air trapping and lung volumes, combined with clinical assessment including mMRC dyspnea scale scoring and laboratory assessment including Cbc abg
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Multidetector volumetric high-resolution computed tomography (≥64 slices, ≤1.0 mm slice thickness) performed during full inspiratory breath-hold and full expiratory breath-hold to quantitatively measure emphysema percentage (EM%), air trapping percentage (AT%), wall thickness (WT), wall area (WA) ,WA% and WT%
Standardized pulmonary function testing performed according to ATS/ERS standards to measure post-bronchodilator forced expiratory volumes (FEV1, FVC) and static lung volumes (RV/TLC ratio).
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연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Emphysema Percentage (EM%) Across GOLD Stages
기간: Baseline
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Volumetric CT assessment quantifying the percentage of low-attenuation lung areas below -950 Hounsfield Units (%LAA-950) across post-bronchodilator GOLD grades (GOLD 1 to 4).
Unit of Measure: Percentage (%)
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Baseline
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Bronchial Wall Thickness (WT) Across GOLD Stages
기간: Baseline
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Volumetric CT quantitative measurement of airway wall thickness evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4).Unit of measurements millimeter (mm).
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Baseline
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Percentage Wall Area (WA%) Across GOLD Stages
기간: Baseline
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Volumetric CT quantitative measurement of bronchial wall area expressed as a percentage of total bronchial cross-sectional area across post-bronchodilator GOLD grades (GOLD 1 to 4).
Unit of Measure: Percentage (%)
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Baseline
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Air Trapping Percentage (AT%) Across GOLD Stages
기간: Baseline
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Volumetric CT assessment evaluating the percentage of low-attenuation lung areas on paired expiratory CT scans (%LAA-856 or expiratory/inspiratory ratio) across post-bronchodilator GOLD grades (GOLD 1 to 4).
Unit of Measure: Percentage (%)
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Baseline
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Percentage Wall Thickness (WT%) Across GOLD Stages
기간: Baseline
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Volumetric CT quantitative measurement of bronchial wall thickness expressed as a percentage of total bronchial outer diameter evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4).
Unit of Measure: Percentage (%)
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Baseline
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Absolute Wall Area (WA) Across GOLD Stages
기간: Baseline
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Volumetric CT quantitative measurement of absolute bronchial wall cross-sectional area evaluated in segmental and subsegmental bronchi across post-bronchodilator GOLD grades (GOLD 1 to 4).
Unit of Measure: Millimeter (mm)
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Baseline
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2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation Coefficient Between CT Emphysema Percentage (EM%) and Spirometric FEV1/FVC Ratio
기간: Baseline (same day or within 1 week of HRCT scan)
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Pearson's or Spearman's correlation coefficient evaluating the relationship between quantitative CT-derived emphysema percentage (%LAA-950) and post-bronchodilator FEV1/FVC ratio measured by spirometry. Unit of Measure: Correlation coefficient (r) |
Baseline (same day or within 1 week of HRCT scan)
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Correlation Coefficient Between CT Air Trapping Percentage (AT%) and Plethysmographic RV/TLC Ratio
기간: Baseline (same day or within 1 week of HRCT scan)
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Pearson's or Spearman's correlation coefficient evaluating the relationship between quantitative expiratory CT air trapping percentage (%LAA-856) and plethysmographic Residual Volume to Total Lung Capacity ratio (RV/TLC expressed as % predicted). Unit of Measure: Correlation coefficient (r) |
Baseline (same day or within 1 week of HRCT scan)
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기타 결과 측정
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation Coefficient Between CT Emphysema Percentage (EM%) and Arterial Oxygen Tension (pO2)
기간: Baseline
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Pearson's or Spearman's correlation coefficient evaluating the relationship between quantitative CT-derived emphysema percentage (%LAA-950) and arterial blood gas oxygen tension (pO2 measured in mmHg). Unit of Measure: Correlation coefficient (r) |
Baseline
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공동 작업자 및 조사자
수사관
수사관
- 수석 연구원: Nesreen Shalabi, Professor of Chest Diseases
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (실제)
기본 완료
연구 완료 (실제)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- MS.25.02.3101
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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