Clinical trial NCT03281590: Stroke and Cerebrovascular Diseases Registry
Official title: Stroke and Cerebrovascular Diseases Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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
Keywords: identification
diagnosis
management
investigation
prevalence
incidence
quality of care
hospitalization
morbidity
disability
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2017-09-13
Enrollment: 4594
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
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.

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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement or worsening in stroke signs/symptoms.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: Department of Neurology, University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Michel Torbey, MD, MPH
role: STUDY_CHAIR
affiliation: University of New Mexico
name: Atif Zafar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of New Mexico
name: Asad Ikram, MD
role: STUDY_DIRECTOR
affiliation: University of New Mexico
name: Mudassir Farooqui, MD, MPH
role: STUDY_DIRECTOR
References: