Florida Cerebrovascular Disease Biorepository and Genomics Center

Ischemic Stroke Clinical Trial

Official title:

Creating a Florida Cerebrovascular Disease Biorepository and Genomics Center

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491980
• Other study ID #: 22-002667
• Status: Recruiting
• Start date: August 2, 2022
• Est. completion date: August 2024

Study information

• Verified date: November 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysmal Subarachnoid Hemorrhage
• Anoxic Brain Injury
• Arteriovenous Fistula
• Asymptomatic Carotid Artery Stenosis
• Brain Injuries
• CADASIL
• Carotid Stenosis
• Cerebral Hemorrhage
• Cerebral Venous Thrombosis
• Cerebrovascular Disease
• Cerebrovascular Disorders
• Constriction, Pathologic
• Dementia, Vascular
• Fibromuscular Dysplasia
• Hemorrhage
• Intracerebral Hemorrhage
• Intracranial Aneurysm
• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Leukoaraiosis
• Moyamoya Disease
• Reversible Cerebral Vasoconstriction Syndrome
• Subarachnoid Hemorrhage
• Thrombosis
• Transient Ischemic Attack
• Unruptured Intracranial Aneurysm
• Vascular Dementia
• Venous Thrombosis

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stroke or TIA at 12 months	Number of participants to experience new diagnosis of TIA or stroke.	1 year
Secondary	Modified Rankin Scale	Measure of overall functional status	1 year

External Links

•   Mayo Clinic Clinical Trials