Identification of microRNAs Involved in Cerebral Collateral Regulation

NCT03905434 | Suspended

• 2 other identifiers: HM200256432018H0199
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

Patients \>18 years of age presenting to Ohio State Wexner Medical Center Emergency department with stroke symptoms, within 6 hours of last know well and found to have acute anterior circulation large vessel occlusion (LVO) will be included in this study. The purpose of this study is to evaluate the differential expression of exosomal microRNAs in patients with stroke due to acute LVO as compared to healthy controls. In addition, the investigators will also evaluate the differential expression of exosomal microRNA in patients with good vs poor collateral grade.

Conditions

Cerebrovascular Disorders

Keywords

Large vessel occlusion; Acute ischemic stroke; microRNA

Outcome Measures

Primary Outcomes (1)

• identification of differentially expressed microRNAs in patients with sudden acute anterior circulation large vessel occlusion, compared to healthy controls.

  The investigators will identify and report the microRNAs differentially expressed in patients with acute large vessel occlusion compared to healthy controls.

  2 years

Secondary Outcomes (1)

• Identification of differentially expressed microRNAs in patients with good vs poor cerebral collateral circulation

  2 years

Study Arms (2)

Control

A total of 15 healthy controls will be enrolled and miRNA samples will be collected

Genetic: miRNA sampling

Stroke

A total of 30 acute stroke patients with large vessel occlusions will be enrolled.

Genetic: miRNA sampling

Interventions

miRNA sampling GENETIC

Blood samples for miRNA testing will be collected from all subjects (control and patients diagnosed with acute ischemic stroke)

Control; Stroke

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients aged \>18 years presenting to the Emergency Department at Ohio State Wexner Medical Center with acute ischemic stroke within 6 hours of last known well will be screened. The investigators will include patients with acute anterior circulation LVO as identified by CT Angiogram. Healthy subjects will be used as controls to assess differentially expressed miRNAs specific to stroke population.

You may qualify if:

• Age 18 years or older.
• Diagnosis of Acute Ischemic Stroke secondary to LVO
• LVO from presumed embolic source (\<50% ICA)
• CT perfusion/RAPID images showing salvageable penumbra (evaluated by PI)

You may not qualify if:

• \>50% stenosis of internal carotid artery
• \>50% stenosis of bilateral vertebral arteries.
• Patients with moderate to severe intracranial atherosclerotic disease as seen in CTA of head and neck.
• Known moderate to severe PVD or symptomatic CAD
• Past medical history of stent or coronary artery bypass surgery
• Prisoners
• Pregnant women
• Previous stroke within 30 days
• Intracranial vascular malformation or evidence of moya-moya disease
• Serious advanced or terminal illness per judgment of the investigator with life expectancy \<1yr
• Known allergy to iodine that precludes CTA or CTP studies
• Presumed septic embolus or suspected bacterial endocarditis

Sponsors & Collaborators

• Virginia Commonwealth University: lead
• Ohio State University: collaborator

Study Sites (2)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

microRNA sampling

MeSH Terms

Conditions

Cerebrovascular Disorders; Ischemic Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke

Study Officials

• Shraddha Mainali, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: April 5, 2019
• Study Start: August 14, 2018
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)