RECRUITING

Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The overall goal of the DISCOVERY study is to better understand what factors contribute to changes in cognitive (i.e., thinking and memory) abilities in patients who experienced a stroke. The purpose of the study is to help doctors identify patients at risk for dementia (decline in memory, thinking and other mental abilities that significantly affects daily functioning) after their stroke so that future treatments may be developed to improve outcomes in stroke patients. For this study, a "stroke" is defined as either (1) an acute ischemic stroke (AIS, or blood clot in the brain), (2) an intracerebral hemorrhage (ICH, or bleeding in the brain), (3) or an aneurysmal subarachnoid hemorrhage (aSAH, or bleeding around the brain caused by an abnormal bulge in a blood vessel that bursts). The investigators hypothesize that: 1. The size, type and location of the stroke play an important role in recovery of thinking and memory abilities after stroke, and pre-existing indicators of brain health further determine the extent of this recovery. 2. Specific stroke events occurring in individuals with underlying genetic or biological risk factors can cause further declines in brain heath, leading to changes in thinking and memory abilities after stroke. 3. Studying thinking and memory alongside brain imaging and blood samples in patients who have had a stroke allows for earlier identification of declining brain health and development of individualized treatment plans to improve patient outcomes in the future.

Official Title

Determinants of Incident Stroke Cognitive Outcomes and Vascular Effects on RecoverY

Quick Facts

Study Start:2021-03-05
Study Completion:2025-11-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04916210

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years
  2. 2. Admitted to the hospital with a diagnosis of acute ischemic stroke (AIS), intracerebral hemorrhage (ICH), or aneurysmal subarachnoid hemorrhage (aSAH)
  3. 3. Radiographic confirmatory evidence of: (1) AIS (based on a focal area of restricted diffusion on MRI), (2) non-traumatic ICH (based on evidence of acute parenchymal hemorrhage CT or brain MRI) or (3) non-traumatic acute aSAH (based on evidence of subarachnoid hemorrhage on CT or MRI and evidence of aneurysm on CT angiography, MR angiography, or conventional catheter-based angiography)
  4. 4. Able to complete baseline visit in person or by phone within 6 weeks of stroke onset
  5. 5. Able to provide informed consent by self or proxy
  6. 6. Fluent in English or Spanish prior to stroke onset
  1. 1. Documented history of pre-stroke dementia or fails dementia pre-screen
  2. 2. Concurrently enrolled into a study that is not approved under the DISCOVERY Co-Enrollment Policy
  3. 3. Unable to complete study protocol (advanced directives such as comfort measures only, or inability to complete the study due to severe medical/behavioral co-morbidities), as determined by physician investigator during screening process
  4. 4. Contraindication to MRI: presence of electrically, magnetically, or mechanically activated implants (such as cardiac pacemakers, cochlear implants, implanted pumps); or metallic clips in the brain
  5. 5. Age \<50 years
  6. 6. Biologically female individuals who are pregnant or seeking to become pregnant
  7. 7. Known to have one of the following genetic conditions which can increase the risk of developing cancer: Cowden disease, Lynch syndrome, hypogammaglobulinemia, Wiskott-Aldrich syndrome, Down's syndrome.

Contacts and Locations

Study Contact

James Meschia, MD
CONTACT
904-953-6515
meschia.james@mayo.edu

Principal Investigator

Natalia Rost, MD, MPH
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Steven Greenberg, MD, PhD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Barrow Neurological Institute
Phoenix, Arizona, 85013
United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027
United States
Cedars Sinai Medical Center
Los Angeles, California, 90048
United States
University of California Los Angeles
Los Angeles, California, 90095
United States
University of California San Diego
San Diego, California, 92037
United States
University of Colorado
Denver, Colorado, 80045
United States
Mayo Clinic
Jacksonville, Florida, 32224
United States
University of Miami Health System
Miami, Florida, 33125
United States
The University of Chicago Medical Center
Chicago, Illinois, 60637
United States
Indiana University
Indianapolis, Indiana, 46202
United States
University of Iowa
Iowa City, Iowa, 52242
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States
Boston Medical Center
Boston, Massachusetts, 02118
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
University of Minnesota Health
Minneapolis, Minnesota, 55455
United States
Mayo Clinic
Rochester, Minnesota, 55902
United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216
United States
Montefiore Medical Center
Bronx, New York, 10467
United States
Duke University Medical Center
Durham, North Carolina, 27708
United States
Wake Forest Baptist Health
Winston-Salem, North Carolina, 27157
United States
University of Cincinnati
Cincinnati, Ohio, 45219
United States
The Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States
Methodist University Hospital
Memphis, Tennessee, 38104
United States
Houston Methodist Research Institute
Houston, Texas, 77030
United States
UTHealth
Houston, Texas, 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
United States
University of Utah
Salt Lake City, Utah, 84132
United States
University of Virginia
Charlottesville, Virginia, 22903
United States
University of Washington, Harborview Medical Center
Seattle, Washington, 98104
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Natalia Rost, MD, MPH, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital
  • Steven Greenberg, MD, PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

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 Registration Dates

Study Start Date2021-03-05
Study Completion Date2025-11-30

Study Record Updates

Study Start Date2021-03-05
Study Completion Date2025-11-30

Terms related to this study

Additional Relevant MeSH Terms

  • Ischemic Stroke
  • Intracerebral Hemorrhage
  • Subarachnoid Hemorrhage
  • Dementia, Vascular
  • Mild Cognitive Impairment
  • Vascular Cognitive Impairment