Analysis With Clusters of QUAntitative Tomodensitometric Vascular, bronchIal and Parenchymal Pulmonary Parameters for COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

— ACQUAVIP  

Official title:

Analysis With Clusters of QUAntitative Tomodensitometric Vascular, bronchIal and Parenchymal Pulmonary Parameters for COPD Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03337854
• Other study ID #: 2017/44
• Status: Not yet recruiting
• Phase: N/A
• First received: October 24, 2017
• Last updated: November 27, 2017
• Start date: December 20, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: November 2017
• Source: University Hospital, Bordeaux
• Contact: François LAURENT, MD, PhD
• Phone: +335 57 65 63 68
• Email: francois.laurent[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic obstructive pulmonary disease (COPD) is caused by tobacco consumption. The goal is to characterize on clinical and radiological data, using computed tomography, this illness in order to improve diagnostic and be able to evaluate the prognostic of each patient.

Description:

Chronic obstructive pulmonary disease (COPD) is characterized by emphysematous destruction of pulmonary parenchyma, airway obstruction that participate in chronic temporary obstruction of airways. COPD has multiple clinical presentations that define phenotypes but doesn't take into account those anatomo-pathologic modifications. Moreover, the prognostic interest of those structural alteration is unknown. Until now, only PFT allowed to define the severity of the disease, whereas multiple others tools may be useful, such as, symptoms scores, exacerbation frequencies, denutrition. Those structural alterations are available using computed tomography (CT), that may also have an interest in prognostic or in treatment follow- up.

CT is widely used in clinical practice for COPD patients at basal state and in exacerbations. Quantitative CT is able to combine acquisition of objective and reproductible informations on parenchymal destruction (emphysema), bronchial wall remodeling, and pulmonary vessels alteration. The investigators' team developed software tools to determine quantitative structural modifications of airways, emphysema and small pulmonary vessels1,2.

The team has been able to build a score "Paw score" combining PaO2 with CT parameters of bronchial wall thickness and small pulmonary vessels percentage2. This score allowed to predict the presence of severe pulmonary hypertension in patients with COPD. Pulmonary hypertension is a complication of COPD that increase morbi-mortality.

The hypothesis is that morphological quantitative analysis combined with structural alterations of airways has a prognostic interest.

The main goal is to determine morphological phenotypes of COPD using a cluster analysis combining emphysema, bronchial wall thickness and pulmonary vessels.

The other main goal is to predict evolution of COPD patients based on clinical outcomes (exacerbations frequency, mortality, mMRC, SGQLQ) and lung function testing (decline in FEV-1 TLCO, PaO2).

The team also wants to analyze clinical data of survival, exacerbation and symptoms in following years of the CT of each cluster in historic-prospective way.

The secondary goals are to describe clinical, functional and biological clusters. Analyse of correlations will be studied. Moreover, we will investigate the interest of the "Paw score" as a prognostic marker and as a correlated parameter.

This is a retrospective study. We want to take information from the year before CT, to the year after CT. At the date of the consultation concomitant with CT we want to know all the clinical, functional and biological data of each patient.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: December 1, 2018
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Age = 40 years

• Inhalated toxic exposure:

• Tobacco exposure (present or past, over 10 pack years)

• And/or professional exposure to a toxic

• Obstructive syndrome with a FEV1/FVC = 0.7 after inhalation of a bronchodilatator and measured at stable state (without exacerbation)

• Computed tomography performed without injection contrast during common care

Exclusion Criteria:

• Patients with an exacerbation within 6 weeks before computed tomography

• Artefacts movements on computed tomography incompatible with quantitative analyse

• Broncho-pulmonary cancer (old or present)

• History of pulmonary surgery

• No follow-up for 1 year after scan

• Opposition of the patient to the use of his data (clinical, functional and imaging).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Bordeaux	Transitionnal Research International Laboratory

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of pack per year of tobacco	Number of pack per year of tobacco	Day 1
Other	Clinical scores	Score COPDAssessmentTest "CAT" Scale range: minimum value: 0, maximum value: 40. Only total score is reported. Higher values are considered to be bad outcome. Subscale are not reported, but there are combined by summed to compute the total score.	Day 1
Other	Clinical scores	Score St Georges Scale range: minimum value: 0, maximum value: 3989.4. Only total score is reported. Higher values are considered to be bad outcome. Subscale (symptoms, activities, impact) are not reported, but there are combined by summed to compute the total score.	Day 1
Other	Clinical scores	Score mMRC (Medical Research Council ) Scale range: minimum value: 0, maximum value: 4. Only total score is reported. Higher values are considered to be bad outcome.	Day 1
Other	Clinical scores	Score Global Initiative for Chronic Obstructive Lung Disease (GOLD) Scale range: minimum value: 0, maximum value: 4. Only total score is reported. Higher values are considered to be bad outcome.	Day 1
Other	Clinical data	Six minute walk test (meters, and % predicted)	Day 1
Other	Pulmonary function test	Forced Expiratory Volume - FEV1 (L)	Day 1
Other	Pulmonary function test	Forced Expiratory Volume/ Forced Volume Capacity (FEV1/FVC)(%)	Day 1
Other	Pulmonary function test	value of KCO (Carbon Monoxide Diffusing Capacity (DLCO) divided by Alveolar Volume(VA))	Day 1
Other	Pulmonary function test	transfer factor of the lung for carbon monoxide (TLCO)	Day 1
Other	Pulmonary function test	total lung capacity (TLC)	Day 1
Other	Arterial blood gazes	pH	Day1
Other	Arterial blood gazes	Partial pressure of oxygen in arterial blood (PaO2) in mmHg	Day1
Other	Arterial blood gazes	Partial pressure of carbon dioxide in arterial blood in mmHg.	Day1
Other	Arterial blood gazes	Hemoglobin (g/dL)	Day1
Other	Arterial blood gazes	carboxyhemoglobin (%)	Day1
Other	Biology	C-reactive protein; cross-reacting protein (mg/l).	Day1
Other	Biology	a1-antitrypsin (mg/l).	Day1
Other	Clinical parameter	weight (kilograms)	Day1
Other	Clinical parameter	Height (meters)	Day1
Other	Clinical parameter	comorbidities	Day1
Primary	Phenotypes of Chronic obstructive pulmonary disease (COPD)	Measure of emphysema	Day 1
Primary	Phenotypes of Chronic obstructive pulmonary disease (COPD)	Measure of proximal bronchial wall thickness	Day 1
Primary	Phenotypes of Chronic obstructive pulmonary disease (COPD)	Measure of dimensions of the pulmonary arteries	Day 1
Primary	Phenotypes of Chronic obstructive pulmonary disease (COPD)	Measure of ratio of main pulmonary artery over aoarta diameter	Day 1
Secondary	Clinical data of survival	Date of death	Day 1
Secondary	Exacerbations	Number of exacerbations	Day 1