Clinical Trials Logo
  1. Home
  2. Ischemic Stroke
  3. NCT05556395
  4. Details
NCT05556395 Clinical Trial

Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline

Ischemic Stroke Clinical Trial

Official title:
Global Blood-Brain Barrier Disruption and Post-Stroke Cognitive Decline

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05556395
Other study ID # IRB00312030
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 1, 2022
Est. completion date April 1, 2027

Study information
Verified date September 2023
Source Johns Hopkins University
Contact Pooja Patel
Phone 410 502 5355
Email ppate120@jhmi.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this study is to gain a better understanding of why some individuals who have suffered a stroke experience post-stroke cognitive decline. Specifically this study is testing whether global disruption of the blood-brain barrier detected at the time of the stroke is informative about the risk of post-stroke cognitive decline over the next 3 years.

Description:

It is well known that ischemic stroke is a risk factor for developing dementia. Prior studies have shown that after a stroke, there can be a change in the trajectory of cognitive performance with acceleration of decline. The mechanism of this phenomenon has not been established. It is known that vascular changes in the brain, referred to as cerebral small vessel disease, are associated with cognitive decline and dementia. Cerebral small vessel disease is readily seen on MRI scans of the brain, and the larger the burden of these findings, the higher the risk of cognitive deficits. Disruption of the blood-brain barrier has been implicated in the development of the changes seen on MRI. Acute stroke has been shown to disrupt the blood-brain barrier, even in parts of the brain not directly affect by the stroke. The investigators hypothesize that when there is diffuse blood-brain barrier disruption in response to an acute stroke it sets off a cascade of changes in the brain that lead to post-stroke cognitive decline.

Recruitment information / eligibility
Status Recruiting
Enrollment 150
Est. completion date April 1, 2027
Est. primary completion date April 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Acute ischemic stroke demonstrated on an MRI scan that includes perfusion imaging with an exogenous contrast agent Exclusion Criteria: - Inability to perform telephone-based cognitive assessments

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Johns Hopkins Hospital Baltimore Maryland

Sponsors (1)
Lead Sponsor Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in Cognition (Cognitive Decline) Serial telephone-based cognitive assessments will be performed to detect cognitive changes (cognitive decline). Assessments occur every 6 months for 3 years
See also
  Status Clinical Trial Phase
Recruiting NCT05196659 - Collaborative Quality Improvement (C-QIP) Study N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Completed NCT03281590 - Stroke and Cerebrovascular Diseases Registry
Recruiting NCT05518305 - Platelet Expression of FcγRIIa and Arterial Hemodynamics to Predict Recurrent Stroke in Intracranial Atherosclerosis
Recruiting NCT06029959 - Stroke and CPAP Outcome Study 3 N/A
Recruiting NCT03728738 - Zero Degree Head Positioning in Hyperacute Large Artery Ischemic Stroke Phase 3
Terminated NCT03396419 - IMPACT- 24col Collateral Blood Flow Assessment Following SPG Stimulation in Acute Ischemic Stroke (ImpACT-24B Sub-Study)
Recruiting NCT05065216 - Treatment of Acute Ischemic Stroke (ReMEDy2 Trial) Phase 2/Phase 3
Recruiting NCT04897334 - Transcranial Direct Current Stimulation and Rehabilitation to Ameliorate Impairments in Neurocognition After Stroke N/A
Not yet recruiting NCT06462599 - Osteopontin Gene Polymorphism in Stroke Patients in Egypt
Not yet recruiting NCT06026696 - Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Not yet recruiting NCT06032819 - Differentiating Between Brain Hemorrhage and Contrast
Recruiting NCT02910180 - Genetic, Metabolic, and Growth Factor Repository for Cerebrovascular Disorders
Completed NCT03554642 - Walkbot Robotic Training for Improvement in Gait Phase 3
Withdrawn NCT01866189 - Identification of Hypoxic Brain Tissues by F-MISO PET in Acute Ischemic Stroke N/A
Completed NCT02922452 - A Study to Evaluate the Effect of Diltiazem on the Pharmacokinetics (PK) of BMS-986141 in Healthy Subjects Phase 1
Recruiting NCT03041753 - Reperfusion Injury After Stroke Study N/A
Completed NCT02549846 - AdminiStration of Statin On Acute Ischemic stRoke patienT Trial Phase 4
Completed NCT01678534 - Reparative Therapy in Acute Ischemic Stroke With Allogenic Mesenchymal Stem Cells From Adipose Tissue, Safety Assessment, a Randomised, Double Blind Placebo Controlled Single Center Pilot Clinical Trial Phase 2
Completed NCT02610803 - Paroxysmal Atrial Fibrillation in Patients With Acute Ischemic Stroke N/A