Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02389634 |
| Other study ID # |
10BN048 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 2010 |
| Est. completion date |
October 25, 2019 |
Study information
| Verified date |
April 2024 |
| Source |
St. Joseph's Hospital and Medical Center, Phoenix |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of the study is to identify novel genetic and protein markers for the process of
cerebral vasospasm following aneurysmal subarachnoid hemorrhage.
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.
