Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (ECO-COPD)

May 22, 2023 updated by: University Hospital, Grenoble

Cardiovascular Risk and Chronic Obstructive Pulmonary Disease (COPD)

The principal objective of the study is to measure parameters of inflammation, oxidative stress, and vascular, respiratory, and peripheral muscle function parameters, and identify parameters indicative of evolving cardiovascular risk (CVR) in COPD patients, using multivariate analysis.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Reduced lung function is a major risk factor for cardiovascular mortality (CV), regardless of age, sex and history of smoking. Similarly, CV events are known causes of mortality in patients with chronic obstructive pulmonary disease (COPD). The investigators propose to determine the parameters influencing the evolution of CV risk in a cohort of COPD patients followed over 5 years. For this the investigators will study the role of inflammation, oxidative stress, and vascular, respiratory and peripheral muscle function parameters.

In order to study a sufficient number of patients the investigators propose to group data from two cohorts: a first cohort of 121 COPD patients that already exists (currently closed to inclusions but still undergoing follow-up (NCT00404430)) and a new cohort of 150, decompensated or not, COPD patients.

This study is of major scientific interest and will enable to obtain extremely important information to better understand COPD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • La Tronche
      • Grenoble, La Tronche, France, 38700
        • Recruiting
        • university grenoble hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Renaud TAMISIER, ProfessorPhD
        • Sub-Investigator:
          • Patrick LEVY, ProfessorPhD
        • Sub-Investigator:
          • Cécile BOSC, MD
        • Sub-Investigator:
          • Marie DESTORS, MD
        • Sub-Investigator:
          • Sam BAYAT, MD
        • Sub-Investigator:
          • Stéphane DOUTRELEAU, MD
        • Sub-Investigator:
          • François ARBIB, MD
        • Sub-Investigator:
          • Damien VIGLINO, MD
        • Sub-Investigator:
          • Nicolas TERZI, ProfessorPhD
        • Sub-Investigator:
          • Gilles BARONE-ROCHETTE, ProfessorPhD
        • Sub-Investigator:
          • Patrice FAURE, ProfessorPhD
        • Sub-Investigator:
          • Gilbert FERRETTI, ProfessorPhD
        • Sub-Investigator:
          • Bernard WUYAM, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

COPD Patients will be recruited during the consultations in Pneumology Department or in the Laboratory of Sleep (patients with stable COPD) or during their hospitalization in Medical Reanimation Unit (patients with decompensated COPD) at the University Grenoble Hospital.

Description

Inclusion Criteria:

For patients with stable COPD:

  • Men or women aged 18 to 85
  • FEV1/FVC < 70% or proven BPCO
  • Patients who have given their free and informed consent in writing

For patients with decompensated COPD:

  • Men or women aged 18 to 85
  • FEV1/FVC < 70% or proven BPCO

  • At the time of acute respiratory failure (ARF), when admitted to hospital:

    • Respiratory rate > 25 cycles per minute
    • PaCO2 > 45 mmHg
    • blood pH < 7.35

  • When included in the study:

    • pH > 7.33 at the end of ARF, 2 days in a row, or 3 to 7 days post-D1 decompensation (admission to the hospital)
    • Fever < 38.5°C
  • Patients who have given their free and informed consent in writing

Exclusion Criteria:

  • Obvious evolving infection or CRP > 100 mg/L
  • Cardiac decompensation considered the main cause of decompensation or chronic heart failure with LVEF < 45%
  • Evolving neoplasia
  • On antioxidants: N-acetyl-cysteine, selenium, vit. C, vit. E
  • Pregnant or nursing women
  • Patients under tutorship or curatorship
  • Patients participating in a drug clinical research study
  • Patients not affiliated to the French social security system (or equivalent)
  • Patients deprived of liberty or hospitalized without consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change of the pulse wave velocity (PWV)
Time Frame: During 5 years since inclusion (once a year)

Measurement of pulse wave velocity (PWV), which reflects cardiovascular risk (CVR).

This measure will be performed at each visit (V1, V1 bis, V2, V3, V4, V5 and V6).
During 5 years since inclusion (once a year)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Monitoring of COPD exacerbations compared to evolution of PWV
Time Frame: During 5 years since inclusion
Determination of the relationship between exacerbations and the evolution of the PWV.
During 5 years since inclusion
Relationship between the new cardiovascular (CV) events and the evolution of the PWV.
Time Frame: During 5 years since inclusion (once a year)
Follow-up of exacerbations compared to new CV events (including myocardial infarction with or without ST segment elevation, ischemic stroke, unexplained sudden death at 5 years).
During 5 years since inclusion (once a year)
Correlations between the parameters of severity of pulmonary disease and physical activity.
Time Frame: During 5 years since inclusion (once a year)
Measurement of extent of pulmonary disease; exploration of peripheral muscle function; measurement of physical activity; measurements of endothelial function; measurement of cardiac function.
During 5 years since inclusion (once a year)
Prevalence of nocturnal "non-dipping" of blood pressure during COPD.
Time Frame: During 5 years since inclusion (once a year)
Measurement of ambulatory arterial blood pressure during 24 hours
During 5 years since inclusion (once a year)
Impact of sleep disorders and sleep apnea syndrome on the evolution of CVR during COPD.
Time Frame: At inclusion visit
Measurement of sleep disorders and Sleep Apnea Syndrome
At inclusion visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean-Louis PEPIN, ProfessorPHD, university grenoble hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 9, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2029

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC16.245

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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