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

Cognitive Impairment Clinical Trial

— DISCoVeR  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03291340
• Other study ID #: 827852
• Status: Suspended
• Start date: October 26, 2017
• Est. completion date: October 2024

Study information

• Verified date: December 2023
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 42
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of right-to-left shunt on TCD		Baseline
Primary	Presence of cerebrovascular reactivity on TCD		Baseline
Secondary	Volume of ischemic injury		Baseline
Secondary	Location of ischemic injury		Baseline
Secondary	Presence of cognitive impairment		Baseline
Secondary	Type of cognitive impairment		Baseline