ClinicalTrials.gg
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

In context

Stroke

8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.

This study's enrollment of 4,594 is above the median of 152 across 1,968 observational studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

University of New Mexico is the lead sponsor of 313 studies on the registry; 29 are open to participants now.

Of its 25 completed or terminated interventional studies of FDA-regulated products, 23 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. All patients with a diagnosis of Acute Brain injury, , 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, , Acute and Chronic Ischemic and Hemorrhagic Stroke, Subarachnoid hemorrhage, and cerebral venous thrombosis.
  2. Patients who have Epidural Hematoma, Subdural hematoma.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

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.

06

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

07

Study locations

1 site
  • Department of Neurology, University of New Mexico
    Albuquerque, New Mexico 87131-0007, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Jun 2022, 57 months.

Of 835 non-industry observational studies under Stroke, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 92. This study's 57 months is above that.

Counting every sponsor, half of 897 studies reached it within 40 months; a quarter within 18 and three quarters within 85.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2017
First posted
Sep 13, 2017
StartActual
Sep 6, 2017
Primary completionActual
Jun 10, 2022
CompletionActual
Jun 10, 2022
Last update
Aug 22, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03281590
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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