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

December 13, 2023 updated by: Steven Messe, University of Pennsylvania

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

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.

Study Overview

Status

Suspended

Conditions

Study Type

Observational

Enrollment (Estimated)

42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Hospital of the University of Pennsylvania

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Only subjects that are enrolled in the NACC longitudinal cohort (Protocol 068200) will be eligible for this study. Subjects must also agree to participate in the ADCC high-resolution MRI sub-study to be eligible.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cognitively normal elderly
TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study
Cognitive impaired elderly
TCD agitated saline right-to-left shunt study TCD cerebrovascular reactivity study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Presence of right-to-left shunt on TCD
Time Frame: Baseline
Baseline
Presence of cerebrovascular reactivity on TCD
Time Frame: Baseline
Baseline

Secondary Outcome Measures

Outcome Measure
Time Frame
Volume of ischemic injury
Time Frame: Baseline
Baseline
Location of ischemic injury
Time Frame: Baseline
Baseline
Presence of cognitive impairment
Time Frame: Baseline
Baseline
Type of cognitive impairment
Time Frame: Baseline
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pennsylvania

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 26, 2017

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 1, 2024

Study Registration Dates

First Submitted

September 15, 2017

First Submitted That Met QC Criteria

September 19, 2017

First Posted (Actual)

September 25, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2023

Last Update Submitted That Met QC Criteria

December 13, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 827852

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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