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Completed

NCT Number: NCT03291340

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

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females ≥ 60 years of age.
  • Fluent in English.
  • 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.
  • Has consented to participate in the ADCC high-resolution MRI sub-study.
  • NACC longitudinal visit must be within 6 months of the TCD study and brain MRI study.
  • Women: post-menopausal or surgically sterile.
  • Willing and able to complete all required study procedures.
  • Completed 6 grades of education.
  • Geriatric Depression scale less than 6 (assessed within 6 months at the NACC longitudinal visit).

Exclusion criteria

  • Prior clinically symptomatic ischemic or hemorrhagic stroke.
  • Inability to tolerate or contraindication to TCD study in the opinion of an investigator or treating physician.
  • Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.

Treatment and study plan

Primary outcomes

  1. Presence of right-to-left shunt on TCD

    Time frame: Baseline

  2. Presence of cerebrovascular reactivity on TCD

    Time frame: Baseline

Secondary outcomes

  1. Volume of ischemic injury

    Time frame: Baseline

  2. Location of ischemic injury

    Time frame: Baseline

  3. Presence of cognitive impairment

    Time frame: Baseline

  4. Type of cognitive impairment

    Time frame: Baseline

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study 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

Acronym: DISCoVeR

Important dates

Study start
2017
Primary completion
2023
Study completion
2023
First posted
Sep 25, 2017
Registry last updated
Dec 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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