Investigating Multimodally Endothelial Dysfunction in Ocular and Systemic Disease

June 26, 2024 updated by: Universitaire Ziekenhuizen KU Leuven
To explore the distribution of retinal vasculature parameters in patients with different subtypes of cardiovascular and ocular disease.

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.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this interventional cohort study, the investigators aim to evaluate retinal vascular function as assessed by optical coherence tomography angiography, fundus photography and dynamic vessel analysis in patients who share microvascular involvement of their pathology (e.g. chronic kidney disease, cardiac decompensation, neuronal small vessel disease and glaucoma) and age-matched healthy controls. Plasm and skin samples for comparative proteomics and transcriptomics are also taken.

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.
Interventional

Enrollment (Estimated)

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.
1000

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • Belgium
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Recruiting
        • Universitaire Ziekenhuizen UZ/KU Leuven
        • Contact:
        • Sub-Investigator:
          • Mathieu Vandenbulcke, MD, PHD
        • Sub-Investigator:
          • Amaryllis Van Craenenbroeck, MD, PhD
        • Sub-Investigator:
          • Jan Van Eijgen, MD
        • Sub-Investigator:
          • Véronique Cornelissen, MD, PHD
        • Sub-Investigator:
          • Elisabeth Jones, PhD

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adult patients with a confirmed or suspect diagnosis of glaucoma based on intra-ocular eye pressure, visual field defect and structural optic nerve changes, regardless their age.
  • Adult patients with chronic kidney disease regardless their age.
  • Adult patients with heart failure with preserved ejection fraction (HFpEF), regardless their age: symptomatic heart failure with Left Ventricle Ejection Fraction > 50% AND BNP > 35 pg/ml (or NT-proBNP>125 pg/ml) OR signs of diastolic dysfunction according to the European Society of Cardiology guidelines 2016
  • Adult patients with confirmed small vessel disease as is diagnosed on routine neurological imaging, regardless their age.
  • People without history or track record of any relevant pathology, including cardiovascular and renal diseases, regardless their age
  • Capable and willing to participate (informed consent)

Exclusion Criteria:

  • Diabetes
  • Personal medical history of retinal neovascularization.
  • Unable or unwilling to give 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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Chronic kidney disease
Diagnostic test: Optical coherence tomography(-angiography) OCT(A)
OCTA is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood.
Diagnostic test: Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
Diagnostic test: DVA 3.0
IMEDOS GmbH
Diagnostic test: Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
Diagnostic test: SphygmoCor
Sphygmocor Excell
Diagnostic test: Sphygmomanometer
For the measurement of the blood pressure.
Diagnostic test: Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Diagnostic test: Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Diagnostic test: Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Other: Diastolic heart failure
Diagnostic test: Optical coherence tomography(-angiography) OCT(A)
OCTA is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood.
Diagnostic test: Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
Diagnostic test: DVA 3.0
IMEDOS GmbH
Diagnostic test: Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
Diagnostic test: SphygmoCor
Sphygmocor Excell
Diagnostic test: Sphygmomanometer
For the measurement of the blood pressure.
Diagnostic test: Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Diagnostic test: Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Diagnostic test: Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Other: Neuronal small vessel disease
Diagnostic test: Optical coherence tomography(-angiography) OCT(A)
OCTA is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood.
Diagnostic test: Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
Diagnostic test: DVA 3.0
IMEDOS GmbH
Diagnostic test: Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
Diagnostic test: SphygmoCor
Sphygmocor Excell
Diagnostic test: Sphygmomanometer
For the measurement of the blood pressure.
Diagnostic test: Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Diagnostic test: Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Diagnostic test: Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Other: Glaucoma
Diagnostic test: Optical coherence tomography(-angiography) OCT(A)
OCTA is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood.
Diagnostic test: Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
Diagnostic test: DVA 3.0
IMEDOS GmbH
Diagnostic test: Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
Diagnostic test: SphygmoCor
Sphygmocor Excell
Diagnostic test: Sphygmomanometer
For the measurement of the blood pressure.
Diagnostic test: Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Diagnostic test: Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Diagnostic test: Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS
Other: Healthy patients
Diagnostic test: Optical coherence tomography(-angiography) OCT(A)
OCTA is a non-invasive diagnostic tool capable of generating cross-sectional coupes of the retina and choroid. Novel algorithms allow to render a 3-dimensional model of the ocular microcirculation based merely on the motion contrast of the circulating blood.
Diagnostic test: Fundus pictures
Visucam (Zeiss), Topcon NW8 fundus camera, NFC 600 (Crystalvue)
Diagnostic test: DVA 3.0
IMEDOS GmbH
Diagnostic test: Hyperspectral retinal images
Ximea SNm4x4 hyperspectral snapshot camera
Diagnostic test: SphygmoCor
Sphygmocor Excell
Diagnostic test: Sphygmomanometer
For the measurement of the blood pressure.
Diagnostic test: Blood sample
For both routine cardiovascular health biomarkers as well as genetic markers (DNA, mRNA, miRNA).
Diagnostic test: Skin biopsy
Spatial proteomics and transcriptomics for endothelial function.
Diagnostic test: Neuropsychological examination
Moca, Stroop color word test, concept shifting test, COWAT, (R)AVLT, Beck depression inventory, GDS

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
Time Frame
Relative distribution of retinal endothelial reactivity, flow index, vessel density in the different subpopulations.
Time Frame: 3 years
3 years

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
Time Frame
Diagnostic performance of the aforementioned parameters to distinguish the different subpopulations.
Time Frame: 3 years
3 years
The association between these parameters and (1) the presence of risk factors for cardiovascular disease (including biomarkers) and (2) risk factors for disease progression and (3) neuropsychological functioning
Time Frame: 3 years
3 years
Physiological behaviour of retinal vasculature under cardiovascular stress.
Time Frame: 3 years
3 years
Histopathological correlates in dermal microvasculature
Time Frame: 3 years
3 years

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.
Universitaire Ziekenhuizen KU Leuven

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: Ingeborg Stalmans, MD, PhD, Universitaire Ziekenhuizen KU Leuven

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.
July 6, 2021

Primary Completion (Estimated)

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.
December 31, 2024

Study Completion (Estimated)

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 31, 2024

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).
October 5, 2023

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.
June 26, 2024

First Posted (Actual)

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.
July 3, 2024

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.
July 3, 2024

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.
June 26, 2024

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.
September 1, 2023

More Information

Terms related to this study

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.
  • S63649

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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