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

NCT ID: NCT03291340

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

27 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-26

Study Completion Date

2023-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cognitively normal elderly

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

No interventions assigned to this group

Cognitive impaired elderly

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Steven Messe

Associate Professor of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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827852

Identifier Type: -

Identifier Source: org_study_id