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Determining the Impact of Shunting and CerebroVascular Reactivity on 7T MRI (DISCoVeR 7T MRI)

Sponsor
University of Pennsylvania (Other)
Overall Status
Suspended
CT.gov ID
NCT03291340
Collaborator
(none)
42
Enrollment
1
Location
59.2
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to use transcanial doppler (TCD) ultrasound to look for possible risk factors for ischemic brain injury. We will perform contrast TCD with agitated saline contrast to identify and contrast right-to-left shunt (RLS) and breath holding to assess cerebrovascular reactivity (CVR) in the elderly.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    42 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A Pilot Cross-sectional Cohort Study of Right-to-left-shunt, Cerebrovascular Reactivity, Ischemic Infarct Burden on High Resolution MRI, and Cognitive Impairment in Elderly Subjects
    Actual Study Start Date :
    Oct 26, 2017
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Cognitively normal elderly

    TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study
    Cognitive impaired elderly

    TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study

    Outcome Measures

    Primary Outcome Measures

    1. Presence of right-to-left shunt on TCD [Baseline]

    2. Presence of cerebrovascular reactivity on TCD [Baseline]

    Secondary Outcome Measures

    1. Volume of ischemic injury [Baseline]

    2. Location of ischemic injury [Baseline]

    3. Presence of cognitive impairment [Baseline]

    4. Type of cognitive impairment [Baseline]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Males and females ≥ 60 years of age.

    2. Fluent in English.

    3. Part of the NACC longitudinal cohort (Protocol #: 068200) of the PMC/ADCC with consensus conference designation of cognitively normal, Mild Cognitive Impairment, or probable/possible Alzheimer's disease.

    4. Has consented to participate in the ADCC high-resolution MRI sub-study.

    5. NACC longitudinal visit must be within 6 months of the TCD study and brain MRI study.

    6. Women: post-menopausal or surgically sterile.

    7. Willing and able to complete all required study procedures.

    8. Completed 6 grades of education.

    9. Geriatric Depression scale less than 6 (assessed within 6 months at the NACC longitudinal visit).

    Exclusion Criteria:

    1. Prior clinically symptomatic ischemic or hemorrhagic stroke.

    2. Inability to tolerate or contraindication to TCD study in the opinion of an investigator or treating physician.

    3. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital of the University of Pennsylvania Philadelphia Pennsylvania United States 19104

    Sponsors and Collaborators

    • University of Pennsylvania

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Steven Messe, Associate Professor of Neurology, University of Pennsylvania
    ClinicalTrials.gov Identifier:
    NCT03291340
    Other Study ID Numbers:
    • 827852
    First Posted:
    Sep 25, 2017
    Last Update Posted:
    Nov 19, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cognitive Dysfunction

    Study Results

    No Results Posted as of Nov 19, 2021