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

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ClinicalTrials.gov Identifier: NCT03291340
Recruitment Status : Suspended (Recruitment temporarily suspended due to COVID-19 pandemic.)
First Posted : September 25, 2017
Last Update Posted : May 13, 2020
Sponsor:
Information provided by (Responsible Party):
Steven Messe, 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.

Condition or disease
Cognitive Impairment

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Study Type : Observational
Estimated Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : October 26, 2017
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : October 2020

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



Primary Outcome Measures :
  1. Presence of right-to-left shunt on TCD [ Time Frame: Baseline ]
  2. Presence of cerebrovascular reactivity on TCD [ Time Frame: Baseline ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03291340


Locations
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United States, Pennsylvania
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
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Responsible Party: Steven Messe, Associate Professor of Neurology, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03291340    
Other Study ID Numbers: 827852
First Posted: September 25, 2017    Key Record Dates
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders