Identification of Novel Molecular Markers for Vasospasm

Identification of Novel Molecular Markers for Vasospasm From the Cerebrospinal Fluid (CSF) of Patients With Aneurysmal Subarachnoid Hemorrhage

The purpose of the study is to identify novel genetic and protein markers for the process of cerebral vasospasm following aneurysmal subarachnoid hemorrhage.

Study Overview

• Status: Completed
• Conditions: Subarachnoid Hemorrhage; Cerebral Vasospasm

Detailed Description

Cerebral vasospasm is a recognized and poorly understood complication for many patients who have aneurysmal subarachnoid hemorrhage. Constriction of the cerebral arterial vasculature occurs as free subarachnoid blood under high pressure comes into contact with the surfaces of vessels, particularly in the basal cisterns. However, the exact pathophysiology of vasospasm is unknown. Morbidity and mortality rates for vasospasm are high despite improvements in management. Excluding the initial hemorrhage, cerebral vasospasm is recognized as the main cause of substantial disability and death. Cerebral vasospasm kills 7% of patients, and causes severe deficit in another 7%. Cerebral vasospasm almost never occurs before day 3, has maximal incidence at days 6-8, and rarely occurs after day 17. The disorder is clinically characterized by confusion or decreased consciousness with focal neurological deficit.

Experimental evidence suggests that red blood cell hemolysis and subsequent release of oxygen, hemoglobin, reactive oxygen species, and other as yet undescribed mediators are necessary for the development of vasospasm. The goal of this study is to use modern tools of genomics to identify novel molecular markers for the process of vasospasm by studying the release of micro ribonucleic acids (RNA) that are secreted into the cerebrospinal fluid following the initiation of vasospastic cascades. Micro RNA's have recently been identified as important regulators of many cellular processes including cell cycle progression, proliferation, tumor suppressors, oncogenes, and regulators of metabolic pathways. The researchers propose to study the levels of annotated micro RNA's in the cerebrospinal fluid (CSF) of patients who present with subarachnoid hemorrhage from presentation through the hospital stay. The researchers will correlate the level of these micro RNA's with patient clinical presentation, including transcranial Doppler measurements, Glasgow Coma Scale score, vital signs, and angiographic studies. It is well established that the process of vasospasm occurs over the course of many days. Long before vasospasm becomes clinically evident, cellular processes causing spasm are in action and the researchers hope to identify micro RNA mediators of these processes using high throughput screening methods.

• Study Type: Observational
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute at St. Joseph's Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with aneurysmal subarachnoid hemorrhage

Description

Inclusion Criteria:

• Adult patients with aneurysmal subarachnoid hemorrhage within 24-hours of bleed.
• Receive either open vascular clipping or endovascular coiling.

Exclusion Criteria:

• Patients under 18 years of age.
• Patients arriving at the hospital >24-hours post-hemorrhage.
• Patients who are not candidates for further care.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms	Identification of vasospasm via microRNA mediators prior to clinically evident signs and symptoms	30 days

Collaborators and Investigators

• Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Collaborators: Translational Genomics Research Institute
• Investigators: Principal Investigator: Robert F Spetzler, MD, Saint Joseph's Hospital and Medical Center/Barrow Neurological Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): October 25, 2019
• Study Completion (Actual): October 25, 2019

Study Registration Dates

• First Submitted: March 10, 2015
• First Submitted That Met QC Criteria: March 10, 2015
• First Posted (Estimated): March 17, 2015

Study Record Updates

• Last Update Posted (Actual): April 19, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hemorrhages; Hemorrhage; Subarachnoid Hemorrhage; Vasospasm, Intracranial
• Other Study ID Numbers: 10BN048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED