Stroke and Cerebrovascular Diseases Registry

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Ischemic Stroke; Transient Ischemic Attack; Cerebral Infarction; Subarachnoid Hemorrhage; Hemorrhagic Stroke; Acute Brain Injury; Acute Stroke; Cerebral Stroke; Cerebral Ischemia; 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 Type: Observational
• Enrollment (Actual): 4594

Contacts and Locations

Study Locations

• United States
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-0007
      • Department of Neurology, University of New Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with a final/discharge diagnosis of stroke or transient ischemic attack can be included into the Stroke Registry. This includes cases with a principal/primary or secondary diagnosis of:

• Cerebral Infarction
• Intracerebral Hemorrhage (non-traumatic)
• Ischemic Stroke
• Subarachnoid Hemorrhage (non-traumatic)
• Transient Ischemic Attack (TIA)
• Acute Brain Injury
• Cerebral Venous Sinus Thrombosis

The investigators will use the available EMR and databases to search for these patients using relevant ICD-9/10 codes.

Description

Inclusion Criteria:

1. 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.
2. Age >1 years of age.

Exclusion Criteria:

1. 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.
2. Patients who have Epidural Hematoma, Subdural hematoma.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement or worsening in stroke signs/symptoms.	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.	1 year

Collaborators and Investigators

• Sponsor: University of New Mexico

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 6, 2017
• Primary Completion (ACTUAL): June 10, 2022
• Study Completion (ACTUAL): June 10, 2022

Study Registration Dates

• First Submitted: September 11, 2017
• First Submitted That Met QC Criteria: September 11, 2017
• First Posted (ACTUAL): September 13, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 22, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: prevalence; incidence; quality of care; diagnosis; hospitalization; disability; management; morbidity; identification; investigation
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Embolism and Thrombosis; Craniocerebral Trauma; Trauma, Nervous System; Infarction; Brain Infarction; Intracranial Hemorrhages; Intracranial Thrombosis; Intracranial Embolism and Thrombosis; Thromboembolism; Stroke; Ischemic Stroke; Brain Ischemia; Ischemia; Brain Injuries; Ischemic Attack, Transient; Hemorrhage; Thrombosis; Cerebral Infarction; Subarachnoid Hemorrhage; Hemorrhagic Stroke; Cerebrovascular Disorders; Sinus Thrombosis, Intracranial
• Other Study ID Numbers: 17-281

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No