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Stroke and Cerebrovascular Diseases Registry

This study is currently recruiting participants.
Verified September 2017 by University of New Mexico
Sponsor:
ClinicalTrials.gov Identifier:
NCT03281590
First Posted: September 13, 2017
Last Update Posted: September 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of New Mexico
  Purpose
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
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

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Other
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Stroke and Cerebrovascular Diseases Registry

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • Improvement or worsening in stroke signs/symptoms. [ Time Frame: 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.


Estimated Enrollment: 10000
Actual Study Start Date: September 6, 2017
Estimated Study Completion Date: December 31, 2020
Estimated Primary Completion Date: December 31, 2018 (Final data collection date for primary outcome measure)
Groups/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.

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   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.

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281590


Contacts
Contact: Atif Zafar, MD 5052724015 azafar@salud.unm.edu
Contact: Asad Ikram, MD 5052729382 aikram@salud.unm.edu

Locations
United States, New Mexico
Department of Neurology, University of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87131-0007
Contact: Ikram    505-272-9382      
Principal Investigator: Atif Zafar, MD         
Sub-Investigator: Asad Ikram, MD         
Sub-Investigator: Dinesh Jillella, MD         
Sub-Investigator: Saif Bushnaq, MD         
Sponsors and Collaborators
University of New Mexico
Investigators
Study Chair: Christopher S Calder, MD,PhD University of New Mexico
Principal Investigator: Atif Zafar, MD University of New Mexico
Study Director: Asad Ikram, MD University of New Mexico
  More Information

Responsible Party: University of New Mexico
ClinicalTrials.gov Identifier: NCT03281590     History of Changes
Other Study ID Numbers: 17-281
First Submitted: September 11, 2017
First Posted: September 13, 2017
Last Update Posted: September 13, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of New Mexico:
identification
diagnosis
management
investigation
prevalence
incidence
quality of care
hospitalization
morbidity
disability

Additional relevant MeSH terms:
Stroke
Ischemia
Infarction
Brain Injuries
Hemorrhage
Thrombosis
Subarachnoid Hemorrhage
Ischemic Attack, Transient
Cerebral Infarction
Cerebrovascular Disorders
Brain Ischemia
Sinus Thrombosis, Intracranial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Necrosis
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Embolism and Thrombosis
Intracranial Hemorrhages
Brain Infarction
Intracranial Thrombosis
Intracranial Embolism and Thrombosis
Thromboembolism