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Prognostic Significance of the Baroreflex Sensitivity Changes After Acute Ischemic Stroke

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2008 by Far Eastern Memorial Hospital.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00422474
First Posted: January 17, 2007
Last Update Posted: July 10, 2008
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. Read our disclaimer for details.
Information provided by:
Far Eastern Memorial Hospital
  Purpose

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
Cerebrovascular Accident Baroreflexes Autonomic Nervous System Diseases

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Estimated Enrollment: 100
Study Start Date: January 2007
  Eligibility

Information from the National Library of Medicine

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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
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): 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

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 Submitted: January 14, 2007
First Posted: January 17, 2007
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
Stroke
Nervous System Diseases
Immune System Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases