Exploration of Microcirculatory Alteration and Endothelia... | NCT03508089

Studies
Exploration of Microcirculatory Alteration and Endothelial Dysfunction by Adaptive Optics in Multiple Sclerosis

NCT03508089

Sponsor

Versailles Hospital

Status

Unknown status

Last Update Posted

Apr 25, 2018Actual

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Sclerosis, Multiple

Interventions

Ocular fundus on patient with Multiple Sclerosis
Ocular Fundus on voluntary person

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 22, 2017Actual

Primary Completion Date

Oct 26, 2017Actual

Completion Date

Jun 30, 2018Estimated

First Submitted Date

Mar 25, 2018

First Submission Date that Met QC Criteria

Apr 16, 2018

First Posted Date

Apr 25, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2018

Last Update Posted Date

Apr 25, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

It's a pilot, interventional prospective monocentric study. It aims to compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between patients with multiple sclerosis and controls using the technique of adaptive optics.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Control Arm	Other		Other: Ocular Fundus on voluntary person
Multiple Sclerosis Arm	Active Comparator		Other: Ocular fundus on patient with Multiple Sclerosis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ocular fundus on patient with Multiple Sclerosis	Other	Ocular fundus on patient with Multiple Sclerosis	Multiple Sclerosis Arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To compare the wall / lumen ratio (WLR) of retinal arterioles (common marker of microangiopathies) between multiple sclerosis patients and controls using the adaptive optics technique.		Day 0

Secondary Outcomes

Measure	Description	Time Frame
Compare between patients with multiple sclerosis and controls, retinal arteriolar gauges measured by external and internal diameter.		Day 0
Correlate possible changes in arteriolar WLR with internal and external diameter, smoking, age, blood pressure, fatigue (MFIS), cognition (MDT) and disability (EDSS) scores to ambient air and normobaric oxygen.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Patient Inclusion Criteria

Major patient between 18 and 50 years
Patient with relapsing or remitting multiple sclerosis defined according to revised Mc Donald criteria 2010
Written, free and informed consent dated and signed
Patient affiliated to a social security scheme

Control Inclusion Criteria:

Person between the ages of 18 and 50
Written, free and informed consent dated and signed
Person affiliated to a social security scheme
Person with multiple sclerosis

Exclusion Criteria:

Contraindication to the use oxygen (O2): Acute or chronic respiratory insufficiency
Pregnant or lactating woman
Inability to see fundus (cataract), retinopathy, glaucoma
Use of vasoactive substances (eg nasal decongestants, triptans, alkaloids) in the last 48 hours
Use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, ..) and steroids (corticosteroids) in the last 48 hours
Known Diabetes or taking antidiabetics in the last 48 hours
Use of statins in the last 48 hours
Known hypertension or antihypertensive treatment in the last 48 hours
Any cardiac pathology (valvulopathy, angina, ventricular arrhythmia or atrial fibrillation), vascular (arteritis obliterating the lower limbs, stenosis of the arteries with encephalic destiny, coronary artery disease) or significant respiratory (asthma, Chronic obstructive pulmonary disease, interstitial pathology)
Alcohol consumption within 8 hours
Ophthalmoparesis or incapacitating nystagmus (impossibility of correctly evaluating the fundus)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases