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Prognostic Significance of the Baroreflex Sensitivity Changes After Acute Ischemic Stroke

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ClinicalTrials.gov Identifier: NCT00422474
Recruitment Status : Unknown
Verified July 2008 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
First Posted : January 17, 2007
Last Update Posted : July 10, 2008
Sponsor:
Information provided by:
Far Eastern Memorial Hospital

Study Description
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Brief Summary:

After acute stroke, baroreflex sensitivity (BRS) is impaired. This impaired acute stage BRS has been reported to be predictive of worsen outcome years after stroke in general. However, it is not very clear if the impaired acute stroke BRS would actually persist months after the acute stage. It is also not clear that such change, if any, would correlate with the functional outcome or prognosis after stroke.

The trial is to investigate the longitudinal time course of BRS after ischemic stroke up to the 6th month post stroke and to see if there is any correlation of the changes in BRS with the functional outcome parameters using NIHSS and mRS scores throughout this period.


Condition or disease
Cerebrovascular Accident Baroreflexes Autonomic Nervous System Diseases

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Time Perspective: Prospective
Official Title: Noninvasive Study of the Time Course of Baroreflex Sensitivity 6-Month After Acute Ischemic Stroke and the Relation of Its Changes With Post Stroke Prognosis
Study Start Date : January 2007

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MedlinePlus related topics: Allergy
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Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Baroreflex sensitivity can be done within 72 hours of onset of acute ischemic stroke
  • 50-80 years old
  • Must have either brain CT or brain MRI done

Exclusion Criteria:

  • NIHSS score > 10
  • Patient could not cooperate
  • Unstable vital sign
  • Atrial fibrillation
  • Transient ischemic attack patient
  • Diabetic patient
  • Impaired renal function (Cr > 2.26 mg/dl)
  • Unstable angina, acute myocardiac infarction, cardiomyopathy patients
  • Patient who has known autonomic dysfunction
Contacts and Locations
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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): NCT00422474


Contacts
Contact: Siupak Lee, M.D. siupakmd@ms1.hinet.net

Locations
Taiwan
Far Eastern Memorial Hospital Recruiting
Panchiao City, Taipei County, Taiwan, 220
Contact: Siupak Lee, M.D.       siupakmd@ms1.hinet.net   
Principal Investigator: Siupak Lee, M.D.         
Sub-Investigator: Lung Chan, M.D.         
Sub-Investigator: Dong-feng Yeih, M.D.         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Investigators
Principal Investigator: Siupak Lee, M.D. Far Eastern Memorial Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Dr. Siupak Lee, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT00422474     History of Changes
Other Study ID Numbers: FEMH-95-C-012
First Posted: January 17, 2007    Key Record Dates
Last Update Posted: July 10, 2008
Last Verified: July 2008

Keywords provided by Far Eastern Memorial Hospital:
Ischemic stroke
Baroreflex sensitivity
Prognosis
Cardiovascular autonomic regulation

Additional relevant MeSH terms:
Autonomic Nervous System Diseases
Primary Dysautonomias
Hypersensitivity
Nervous System Diseases
Stroke
Immune System Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases