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Microvascular changes and microvascular reactivity in stable patients with Chronic Obstructive Pulmonary Disease using non-invasive retinal imaging

Microvascular changes and microvascular reactivity in stable patients with Chronic Obstructive Pulmonary Disease using non-invasive retinal imaging

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON26359
Enrollment
246
Registered
2016-06-14
Start date
2016-06-21
Completion date
Unknown
Last updated
2024-06-11

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

Conditions

Chronic Obstructive Pulmonary Disease

Interventions

Before and after rehabilitation, microvascular changes and reactivity will be measured using retinal imaging and endothelial function will be analyzed via reactive hyperemia, blood pressure and ankle

Sponsors

VITO and CIRO
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -COPD as a primary diagnosis according to the Global Initiative For Chronic Obstructive Lung Disease (GOLD) definition: ”Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease with some significant extrapulmonary effects that may contribute to the severity in individual patients. Its pulmonary component is characterized by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and associated with an abnormal inflammatory response of the lung to noxious particles or gases”. COPD is diagnosed by a chest physician. -Clinically stable on the basis of clinical picture by chest physician. -Treated according to the current international guidelines. -Permission for voluntary participation. Patients will be asked during baseline assessment and have to sign an informed consent. Patients have the right to withdraw from the study without any negative consequences on their rehabilitation. -Attending the regular rehabilitation program in Ciro+

Exclusion criteria

Exclusion criteria: -Lack of motivation for voluntary participation in this study. -The presence of abnormalities in the lens (e.g. cataract) or retina (e.g. retinal detachment), which makes it impossible to make an image of the retina. -The presence of severe diabetic retinopathy, which makes it impossible to analyze the microvasculature of the retina.

Design outcomes

Primary

MeasureTime frame
Presence of changes in the retinal microvasculature (for example change in vessel caliber, geometric pattern, etc) in patients with COPD.

Secondary

MeasureTime frame
-Endothelial function analyzed via reactive hyperemia, blood pressure and ankle brachial index in patients with COPD. -The effect of a high-intensity exercise on the reactivity of the retinal microvasculature in patients with COPD compared to non-COPD subjects (obtained in an earlier study). -The effect of an 8-week inpatient rehabilitation program on the retinal vessel calibers in patients with COPD. -The association between 1) retinal vessel changes/retinal vascular reactivity and cardiovascular phenotyping (endothelial function, blood pressure, ankle brachial index, AFR), 2) retinal vessel changes/retinal vascular reactivity and relevant outcomes for COPD patients (e.g. lung function, CAT, 6MWT, CPET, CWRT, smoking status; all included in the routine baseline assessment prior to rehabilitation)

Contacts

Public ContactAnouk Vaes

CIRO, expertise centre for chronic organ failure

anoukvaes@ciro-horn.nl+31 (0)475 587602

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)