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CompletedNCT03281590Updated Aug 22, 2022

Stroke and Cerebrovascular Diseases Registry

An observational study in Stroke, Acute Stroke and Acute Brain Injury, sponsored by University of New Mexico. Completed at 1 site in United States. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-22.

Sponsored by University of New Mexico · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
4,594
Ages
1 Year and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
04

Study design

Observational model
Other
Time perspective
Other
Enrollment
4,594 participants (actual)
Target follow-up
1 Year
Patient registry
Yes

Groups and cohorts

  • 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 year

06

Study locations

1 site
  • Department of Neurology, University of New Mexico
    Albuquerque, New Mexico 87131-0007, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03281590
Lead sponsor
University of New Mexico
Responsible party
Sponsor
First posted
Sep 13, 2017
Start date
Sep 6, 2017
Primary completion
Jun 10, 2022
Completion
Jun 10, 2022
Last update
Aug 22, 2022

Study contacts

Michel Torbey, MD, MPH
study chair · University of New Mexico
Atif Zafar, MD
principal investigator · University of New Mexico
Asad Ikram, MD
study director · University of New Mexico
Mudassir Farooqui, MD, MPH
study director · University of New Mexico

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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