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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03337854
Acronym
ACQUAVIP
Enrollment
270
Registered
2017-11-09
Start date
2017-12-20
Completion date
2018-12-01
Last updated
2017-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

prognostic, phenotype, Computed tomography, Chronic Obstructive Pulmonary Disease

Brief 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.

Detailed 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.

Interventions

None listed

Sponsors

Transitionnal Research International Laboratory
CollaboratorUNKNOWN
University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
Phenotypes of Chronic obstructive pulmonary disease (COPD)Day 1Measure of emphysema

Secondary

MeasureTime frameDescription
Clinical data of survivalDay 1Date of death
ExacerbationsDay 1Number of exacerbations

Other

MeasureTime frameDescription
Pulmonary function testDay 1Forced Expiratory Volume - FEV1 (L)
Arterial blood gazesDay1pH
Number of pack per year of tobaccoDay 1Number of pack per year of tobacco
Clinical parameterDay1weight (kilograms)
BiologyDay1C-reactive protein; cross-reacting protein (mg/l).
Clinical scoresDay 1Score 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.
Clinical dataDay 1Six minute walk test (meters, and % predicted)

Countries

France

Contacts

Primary ContactFrançois LAURENT, MD, PhD
francois.laurent@chu-bordeaux.fr+335 57 65 63 68
Backup ContactRkia ACHKIR
rkia.achkir@chu-bordeaux.fr+335 57 62 32 52

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026