Stroke and Cerebrovascular Diseases Registry

Sponsor

University of New Mexico (Other)

Overall Status

Completed

CT.gov ID

NCT03281590

Collaborator

(none)

4,594

Enrollment

Location

57.1

Actual Duration (Months)

80.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a single institutional registry database for the patients with stroke and cerebrovascular diseases. Stroke is the fifth leading cause of death in the United States. Despite extensive research, most of the patients die or suffer from varying degree of post-stroke disabilities due to neurologic deficits. This registry aims to understand the disease and examine the disease dynamics in the local community.

Condition or Disease	Intervention/Treatment	Phase
Stroke Acute Stroke Acute Brain Injury Ischemic Stroke Hemorrhagic Stroke Transient Ischemic Attack Subarachnoid Hemorrhage Cerebral Ischemia Cerebral Infarction Cerebral Stroke Venous Sinus Thrombosis, Cranial

Detailed Description

Stroke is the fifth cause of all-cause mortality in US http://www.cdc.gov/stroke/facts.htm Early identification and treatment not only prevent mortality but also morbidity. Recent advancement in the imaging and diagnostic technique and novel therapeutic modalities has dramatically helped to downgrade stroke from the list of top mortality index in the last 3 years. However, studies determining factors which help predict stroke outcome are still underway and much work needs to be done in this direction. Many factors currently are used to predict stroke outcome with varying results, for e.g. NIHSS is a good predictor of stroke outcome at 3 months; however, the investigators need better predictors, outcome scales or outcome measures which are easy, reliable and has better specificity and sensitivity.

Acute Brain injury, Transient Ischemic Attack is a special category of a neurological condition wherein there is an impending devastating outcome if workup is not completed in a timely fashion. There is an urgent need to do investigations with high-risk patients to prevent stroke and further mortality and morbidity. The abcd2 score can help us to risk stratify the TIA and to predict the chances of stroke in this specific cohort. However, investigators need better identifiers than already present, to improve the patient changes in secondary prophylaxis of stroke prevention http://www.stroke.org/sites/default/files/resources/tia-abcd2-tool.pdf?docID

There is also some correlation of clinical and biochemical predictors in subarachnoid, cerebral venous thrombosis including Hunt and Hess, SAH score, WFNS-SAH grading among others with variable predictive quality. (Rosen et al; Neurocritical Care; April 2005, Volume 2, Issue 2, pp 110-118: Subarachnoid hemorrhage grading scales).

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

4594 participants

Observational Model:

Other

Time Perspective:

Other

Official Title:

Stroke and Cerebrovascular Diseases Registry

Actual Study Start Date :

Sep 6, 2017

Actual Primary Completion Date :

Jun 10, 2022

Actual Study Completion Date :

Jun 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with stroke Patients with the Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis from pre-hospitalization, hospitalization (in-patient) and post hospitalization (clinic) data
Patients without stroke Control subject who have the risk factors but never had stroke.

Outcome Measures

Primary Outcome Measures

Improvement or worsening in stroke signs/symptoms. [1 year]
Prospective and retrospective analysis of patients with the acute brain injury, transient ischemic attack, acute and chronic ischemic and hemorrhagic stroke, subarachnoid hemorrhage, and cerebral venous thrombosis from pre-hospitalization, hospitalization (in-patient) and post hospitalization (clinic) data to determine factors which can predict stroke outcome.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

All patients with a diagnosis of Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis seen in UNMH.
Age >1 years of age.

Exclusion Criteria:

Patients who don't have the diagnosis of Acute Brain injury, Transient Ischemic Attack, Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis.
Patients who have Epidural Hematoma, Subdural hematoma.