Retina is a Marker for Cerebrovascular Heath

Brief Title

Retina is a Marker for Cerebrovascular Heath

Official Title

Retinal Vasoreactivity is a Marker for Cerebral Small Vessel Disease Progression

Brief Summary

      Cerebral small vessel disease (SVD), present in 80-94% of adults over age 65 years, increases
      the risk of stroke by 2-fold, and dementia by 2.3-fold. There is currently no treatment to
      slow SVD progression. This study aims to test whether impaired cerebral and retinal
      vasoreactivity may serve as biomarker for SVD progression, and to evaluate the safety and
      efficacy of cilostazol (antiplatelet agent with vasodilatory and anti-inflammatory
      properties) for the treatment of SVD.
    

Detailed Description

      This is a prospective, observational nested pilot randomized controlled study to discover
      retinal biomarkers that would predict cerebral small vessel disease progression, and evaluate
      the safety/efficacy of cilostazols in slowing SVD progression. Twenty CADASIL, 40 sWMD, 20
      lobar CMB, and 20 age-matched healthy controls from the Mayo Clinic Florida Familial
      Cerebrovascular Disease Registry and neurology clinic will be recruited. All participants
      will undergo OCTA retinal scan, MRI-BOLD brain scan, cognitive battery evaluation, and blood
      sample at baseline and a 12-month follow-up visit. Key outcome measures are: RVR, CVR,
      cognition, WMH volume, and CMB volume. The 40 patients diagnosed in the course of routine
      clinical care with sWMD will be randomized in 1:1 ratio to receive cilostazol 100mg bid (or
      50 mg bid if taking medications known to affect metabolism of cilostazol) or no cilostazol,
      and followed for WMD progression, and secondarily for changes in cognition, RVR and CVR. Flow
      diagram below outlines the study design. Note that in addition to what is shown in the trial
      flow diagram, patients will have telephone visits between baseline and 12 month clinic visits
      biweekly for 3 months and then monthly thereafter. These visits will consist of a survey for
      adverse events and at the 1-, 3-, 6- and 9-month telephone visits patients will also get a
      modified Rankin scale assessment, a Six-item screener (cognitive assessment) and a PHQ-2
      (depression screen).
    

Study Phase

Phase 1/Phase 2

Study Type

Interventional


Primary Outcome

white matter disease volume

Secondary Outcome

 cognition

Condition

Cerebral Small Vessel Diseases

Intervention

Cilostazol

Study Arms / Comparison Groups

 Cilostazol
Description:  Cilostazol 100mg BID

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

40

Start Date

February 9, 2021

Completion Date

December 31, 2026

Primary Completion Date

June 30, 2023

Eligibility Criteria

        Inclusion Criteria:

          -  Age ≥18 yo.

          -  Diagnosis of CADASIL, sporadic WMD or lobar CMB and age-matched healthy controls (eg.
             patient's spouse or unrelated friends without SVD)

        Exclusion Criteria:

          -  Age<18yo

          -  Pregnant

          -  Breast feeding

          -  Unable to follow commands

          -  Unable to tolerate MRI
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Michelle Lin, MD, MPH, 904-953-4519, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04753970

Organization ID

20-000087


Responsible Party

Principal Investigator

Study Sponsor

Mayo Clinic


Study Sponsor

Michelle Lin, MD, MPH, Principal Investigator, Mayo Clinic


Verification Date

February 2021