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

NCT03337854 | Unknown

• 1 other identifier: 2017/44
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

prognostic; phenotype; Computed tomography; Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (4)

• Phenotypes of Chronic obstructive pulmonary disease (COPD)

  Measure of emphysema

  Day 1

• Phenotypes of Chronic obstructive pulmonary disease (COPD)

  Measure of proximal bronchial wall thickness

  Day 1

• Phenotypes of Chronic obstructive pulmonary disease (COPD)

  Measure of dimensions of the pulmonary arteries

  Day 1

• Phenotypes of Chronic obstructive pulmonary disease (COPD)

  Measure of ratio of main pulmonary artery over aoarta diameter

  Day 1

Secondary Outcomes (2)

• Clinical data of survival

  Day 1

• Exacerbations

  Day 1

Other Outcomes (21)

• Number of pack per year of tobacco

  Day 1

• Clinical scores

  Day 1

• Clinical scores

  Day 1

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Population with an age ≥ 40 years and inhalated toxic exposure like Tobacco exposure (present or past, over 10 pack years) and/or professional exposure to a toxic, in presence of obstructive syndrome with a FEV1/FVC ≤ 0.7 after inhalation of a bronchodilatator and measured at stable state (without exacerbation).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Bordeaux: lead
• Transitionnal Research International Laboratory: collaborator

Study Sites (1)

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François LAURENT, MD, PhD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Central Study Contacts

François LAURENT, MD, PhD

CONTACT

+335 57 65 63 68; francois.laurent@chu-bordeaux.fr

Rkia ACHKIR

CONTACT

+335 57 62 32 52; rkia.achkir@chu-bordeaux.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 9, 2017
• Study Start: December 20, 2017
• Primary Completion: January 1, 2018
• Study Completion: December 1, 2018
• Last Updated: November 28, 2017

Record last verified: 2017-11

Locations

FR (1)