Effects of Nycthemeral Variations on Computed Tomography (CT) Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent in Chronic Obstructive Pulmonary Disease (COPD)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Computed tomography (CT) studies considering bronchial dimensions in chronic obstructive pulmonary disease (COPD) have never considered nycthemeral variations. Airway calibre, in COPD patients, exhibits a nycthemeral variations with maximal values around noon and minimal values in the early morning, that persists under long-acting bronchodilator. Furthermore, no study has assessed the possible nycthemeral variations of CT scans parameters reflecting airway remodelling and emphysema extent in COPD patients.
This is a prospective study whose purpose is to assess these variations and their relationships with pulmonary function testing (PFT) in COPD patients.
| Condition | Intervention |
|---|---|
|
COPD CT Nycthemeron |
Radiation: Chest CT scan |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Effects of Nycthemeral Variations on CT Parameters Reflecting Airways Remodelling, and Pulmonary Emphysema Extent in COPD: Comparisons Between CT Scans Obtained in the Morning and in the Afternoon and Relationships With Pulmonary Function Tests |
- Results of CT Thorax parameters reflecting emphysema and airway remodelling [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Data analysis:
- Emphysema index: from B20f reconstructions, calculation of RA960 using Pulmo CT software.
- Airway index: from B60f reconstructions (1mm-thick every 0.7 mm), calculations of luminal area and wall area for several bronchi.
- Results of pulmonary function tests [ Time Frame: 4 hours ] [ Designated as safety issue: No ]Pulmonary function tests will be performed in the morning (T0) and in the afternoon (T0+8h): vital capacity (VC), forced vital capacity (FVC), functional residual capacity (FRC), total lung capacity (TLC), residual volume (RV), forced expiratory volume in one second (FEV1), diffusion lung capacity for carbon monoxide will be measured.
| Enrollment: | 20 |
| Study Start Date: | March 2010 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
COPD
COPD patients aged 40 or more, with a smoking history of > 10 pack-years, a post-bronchodilator FEV1/VC < 0.7 and an optimal treatment according to GOLD guidelines will be included. Exclusion criteria are: COPD exacerbation or respiratory infection in the 4 weeks before the begin of the study, concomitant pulmonary disease (tuberculosis, significant bronchiectasis, lung cancer), pulmonary resection, active malignancy or malignancy of any organ system within the past 5 years.
|
Radiation: Chest CT scan
Supine CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length)
|
Detailed Description:
Patients : COPD patients aged 40 years or more, with a smoking history of > 10 pack-years (PY), a post-bronchodilator forced expiratory volume in one second to vital capacity ratio (FEV1/VC) < 0.7 and an optimal treatment according to GOLD guidelines will be included. Exclusion criteria are: COPD exacerbation or respiratory infection in the 4 weeks before the begin of the study, concomitant pulmonary disease (tuberculosis, significant bronchiectasis, lung cancer), pulmonary resection, active malignancy or malignancy of any organ system within the past 5 years.
Procedures: All measurements will be performed on the same day, after obtaining the written informed consent of the patient. Medical history, smoking status and patient's treatment will be collected.
At 08:00 AM (T0): PFT will be performed, including vital capacity (VC), forced vital capacity (FVC), functional residual capacity (FRC), total lung capacity (TLC), residual volume (RV), forced expiratory volume in one second (FEV1), diffusion lung capacity for carbon monoxide (DLCO), and alveolar volume (VA) measurements (either in absolute values and percentage of predicted values). A first CT scan will be performed using the following technique:
- Supine CT scan after full inspiration.
- Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) 90 quality ref mAs with care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm
- Reconstructions parameters: B60f 1mm-thick every 0.7 mm, B20f 1mm-thick every 10.0 mm, B35f 1mm-thick every 0.7 mm, B60f 5mm-thick every 5.0 mm and B35f 5mm-thick every 5.0 mm
At 04:00 PM (T0+8h): PFT will be performed, including vital capacity (VC), forced vital capacity (FVC), functional residual capacity (FRC), total lung capacity (TLC), residual volume (RV), forced expiratory volume in one second (FEV1), diffusion lung capacity for carbon monoxide (DLCO), and alveolar volume (VA) measurements (either in absolute values and percentage of predicted values). A second CT scan will be performed using the following technique:
- Supine CT scan after full inspiration.
- Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length) 90 quality ref mAs with care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm
- Reconstructions parameters: B60f 1mm-thick every 0.7 mm, B20f 1mm-thick every 10.0 mm, B35f 1mm-thick every 0.7 mm, B60f 5mm-thick every 5.0 mm and B35f 5mm-thick every 5.0 mm
Data analysis:
- Emphysema index: from B20f reconstructions, calculation of RA960 using Pulmo CT software.
- Airway index: from B60f reconstructions (1mm-thick every 0.7 mm), calculations of luminal area and wall area for several bronchi.
Statistical analyses : Comparisons of CT parameters values or derived values (for example : wall area to airway area ratio) reflecting emphysema and airways remodelling measured on CT scans obtained à T0 and T0+8h. Correlations with PFT values and derived values.
Eligibility| Ages Eligible for Study: | 40 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
COPD patients aged 40 or more, with a smoking history of > 10 PY, a post-bronchodilator FEV1/VC < 0.7 and an optimal treatment according to GOLD guidelines will be included. Exclusion criteria are: COPD exacerbation or respiratory infection in the 4 weeks before the begin of the study, concomitant pulmonary disease (tuberculosis, significant bronchiectasis, lung cancer), pulmonary resection, active malignancy or malignancy of any organ system within the past 5 years.
Inclusion Criteria:
- age 40 or more
- smoking history > 10 pack-years
- post bronchodilator FEV1/VC < 0.7
- optimal treatment according to GOLD guidelines
Exclusion Criteria:
- COPD exacerbation or infection in the 4 weeks before the study
- concomitant pulmonary disease (tuberculosis, significant bronchiectasis, lung cancer)
- pulmonary resection
- active malignancy or malignancy of any organ system within the past 5 years
Contacts and Locations| Belgium | |
| C.H.U Saint-Pierre | |
| Brussels, Belgium, 1000 | |
| Study Director: | Pierre Alain GEVENOIS, MD, PhD | Erasme University Hospital |
More Information
Publications:
| Responsible Party: | Maxime HACKX, Maxime HACKX, MD, Erasme University Hospital |
| ClinicalTrials.gov Identifier: | NCT01192932 History of Changes |
| Other Study ID Numbers: | AK/10-02-13/3863 |
| Study First Received: | August 31, 2010 |
| Last Updated: | July 3, 2012 |
| Health Authority: | Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment |
Additional relevant MeSH terms:
|
Emphysema Pulmonary Disease, Chronic Obstructive Pulmonary Emphysema Lung Diseases, Obstructive Airway Remodeling |
Pathologic Processes Lung Diseases Respiratory Tract Diseases Pathological Conditions, Anatomical |
ClinicalTrials.gov processed this record on May 22, 2013