Changes in Microcirculation and Functional Status During Exacerbation of COPD

NCT ID: NCT03250000

Last Updated: 2017-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-08

Study Completion Date

2020-07-01

Brief Summary

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This study investigates the influence of acute exacerbation of chronic obstructive pulmonary disease (COPD) on retinal microcirculation, on functional status and also investigates the prognostic value of retinal vessel caliber assessment in terms of hospitalization and mortality during 2 years of follow-up.

Detailed Description

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Recent findings suggest that patients with chronic obstructive pulmonary disease (COPD) are at increased risk for myocardial infarction and stroke during periods of acute exacerbation. These findings might be related to acute endothelial changes associated to increased systemic inflammation. Changes in the microcirculation can be explored noninvasively by studying retinal blood vessels that are visualized in fundus images. The retinal blood vessels have anatomical and physiological features that are comparable with the coronary circulation.

Patients with COPD experience quadriceps muscle weakness, which worsens during hospitalization by \~1% per day. This is the result of physical inactivity, in combination with increased oxidative stress and systemic inflammation. Physical inactivity is induced by the hospital environment, but is also related to symptoms of dyspnea caused by increased work of breathing and oxygen desaturation.

Muscle weakness and physical inactivity are associated to poor functional status and recurrent hospital admissions, independent of pulmonary impairment, which makes those patients with frequent exacerbations prone to enter a vicious cycle.

Simple functional screening tests during hospital stay might enable us to quantify the impact of a hospitalization on functional status and to identify patients at risk for repeated exacerbations.

Conditions

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COPD Exacerbation Physical Activity Retinal Vascular

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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COPD-stable

Stable COPD patients at pulmonology consultation in Ziekenhuis Oost-Limburg (ZOL) Genk

No interventions assigned to this group

COPD-Ex

Patients admitted to the respiratory ward of ZOL Genk with a diagnosis of acute exacerbation, based on the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Stable COPD (post-bronchodilator forced expiratory volume / forced vital capacity \< 0.7), no exacerbations in the previous weeks. COPD patients with diagnosis of acute exacerbation, based on the GOLD criteria.

Exclusion Criteria

* Inability to walk without support from others
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Martijn Spruit

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ziekenhuis Oost-Limburg

Genk, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Chris Burtin, PhD

Role: CONTACT

0032499387898

Martijn Spruit, PhD

Role: CONTACT

+32011269370

Facility Contacts

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Michiel Thomeer, MD, PhD

Role: primary

003289327038

Other Identifiers

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COPD-EX HasseltU

Identifier Type: -

Identifier Source: org_study_id

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