Florida Cerebrovascular Disease Biorepository and Genomics Center

Creating a Florida Cerebrovascular Disease Biorepository and Genomics Center

The purpose of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida, which will include collecting medical history information and blood from subjects affected by cerebrovascular disease. The information and blood samples collected may be used in future research for the study of cerebrovascular disease and to learn about, prevent or treat other health problems.

Study Overview

• Status: Recruiting
• Conditions: Ischemic Stroke; Transient Ischemic Attack; Moyamoya Disease; Subarachnoid Hemorrhage; Vascular Dementia; Arteriovenous Fistula; Aneurysmal Subarachnoid Hemorrhage; Leukoaraiosis; Cerebrovascular Disease; Intracerebral Hemorrhage; Anoxic Brain Injury; Reversible Cerebral Vasoconstriction Syndrome; CADASIL; Unruptured Intracranial Aneurysm; Fibromuscular Dysplasia; Cerebral Venous Thrombosis; Asymptomatic Carotid Artery Stenosis; Carotid Artery Stenosis Symptomatic; Non-Aneurysmal Perimesencephalic Subarachnoid Haemorrhage

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
      • Contact: Maria Caruso; Phone Number: 37897 904-953-7897; Email: STROKERESEARCH@mayo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects identified with a history of cerebrovascular disease will be recruited from both the in-patient and outpatient services at Mayo Clinic Florida.

Description

Inclusion Criteria:

• Affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid hemorrhage, leukoaraiosis, arteriovenous fistula, reversible cerebral vasoconstriction syndrome (RCVS), and CADASIL.

Exclusion Criteria:

• All patients with the following known or suspected virulent microorganisms causing an active or latent infection will be excluded from the study:

• Human immunodeficiency virus (HIV);
• Any viral hepatitis;
• West Nile virus (WNV);
• Influenza virus;
• Tuberculosis (TB);
• Any bacteremia;
• Any fungemia;
• Any prionopathy.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stroke or TIA at 12 months	Number of participants to experience new diagnosis of TIA or stroke.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modified Rankin Scale	Measure of overall functional status	1 year

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: James Meschia, MD, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2022
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Wounds and Injuries; Neurocognitive Disorders; Congenital Abnormalities; Genetic Diseases, Inborn; Embolism and Thrombosis; Pathological Conditions, Anatomical; Craniocerebral Trauma; Trauma, Nervous System; Brain Ischemia; Carotid Artery Diseases; Dementia; Infarction; Stroke; Brain Infarction; Cardiovascular Abnormalities; Vascular Malformations; Cerebral Arterial Diseases; Intracranial Arterial Diseases; Intracranial Hemorrhages; Cerebral Small Vessel Diseases; Intracranial Arteriosclerosis; Leukoencephalopathies; Aneurysm; Arteriovenous Malformations; Vascular Fistula; Fistula; Cerebral Infarction; Ischemic Stroke; Ischemia; Brain Injuries; Ischemic Attack, Transient; Hemorrhage; Carotid Stenosis; Thrombosis; Venous Thrombosis; Constriction, Pathologic; Moyamoya Disease; Subarachnoid Hemorrhage; Cerebral Hemorrhage; Dementia, Vascular; Cerebrovascular Disorders; Intracranial Aneurysm; Arteriovenous Fistula; CADASIL; Fibromuscular Dysplasia; Leukoaraiosis
• Other Study ID Numbers: 22-002667

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