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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03291340

Acronym

DISCoVeR

Enrollment

Registered

2017-09-25

Start date

2017-10-26

Completion date

2023-10-01

Last updated

2024-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Impairment

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

60 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Presence of right-to-left shunt on TCD	Baseline
Presence of cerebrovascular reactivity on TCD	Baseline

Secondary

Measure	Time frame
Volume of ischemic injury	Baseline
Location of ischemic injury	Baseline
Presence of cognitive impairment	Baseline
Type of cognitive impairment	Baseline

Countries

United States

Outcome results