Clinical trial NCT05491980: Florida Cerebrovascular Disease Biorepository and Genomics Center
Official title: Creating a Florida Cerebrovascular Disease Biorepository and Genomics Center
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cerebrovascular Disease
Ischemic Stroke
Transient Ischemic Attack
Intracerebral Hemorrhage
Aneurysmal Subarachnoid Hemorrhage
Vascular Dementia
Anoxic Brain Injury
Unruptured Intracranial Aneurysm
Carotid Artery Stenosis Symptomatic
Asymptomatic Carotid Artery Stenosis
Non-Aneurysmal Perimesencephalic Subarachnoid Haemorrhage
Cerebral Venous Thrombosis
Moyamoya Disease
Fibromuscular Dysplasia
Subarachnoid Hemorrhage
Leukoaraiosis
Arteriovenous Fistula
Reversible Cerebral Vasoconstriction Syndrome
CADASIL
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Stroke or TIA at 12 months
timeFrame: 1 year
Secondary outcomes:
measure: Modified Rankin Scale
timeFrame: 1 year
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: James Meschia, MD
role: PRINCIPAL_INVESTIGATOR
References: