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

Completed

• Conditions: Cognitive Impairment

• Registration Number: NCT03291340
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-25
• Study Start: 2017-10-26
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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).

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Presence of cerebrovascular reactivity on TCD	Baseline
Presence of right-to-left shunt on TCD	Baseline

Secondary Outcome Measures

Name	Time	Method
Volume of ischemic injury	Baseline
Location of ischemic injury	Baseline
Presence of cognitive impairment	Baseline
Type of cognitive impairment	Baseline

Trial Locations

Locations (1)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States