Cerebrovascular AccidentNCT00422474
Prognostic Significance of the Baroreflex Sensitivity Changes After Acute Ischemic Stroke
An observational study of Cerebrovascular Accident and Baroreflexes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Cerebrovascular Accident, Baroreflexes, Autonomic Nervous System Diseases
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2007to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- NIHSS score > 10
- Patient could not cooperate
- Unstable vital sign
- Atrial fibrillation
- Transient ischemic attack patient
- Diabetic patient
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- Impaired renal function (Cr > 2.26 mg/dl)
- Unstable angina, acute myocardiac infarction, cardiomyopathy patients
- Patient who has known autonomic dysfunction
Trial locations and contacts
1 site in 1 country.
Siupak Lee, M.D. contact
Taiwan1 site, 1 recruiting
- Recruiting
Far Eastern Memorial Hospital
Banqiao District, Taipei, 220
Siupak Lee, M.D., siupakmd@ms1.hinet.net
Siupak Lee, M.D.
About this study
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
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.
- Keywords
- Ischemic stroke, Baroreflex sensitivity, Prognosis, Cardiovascular autonomic regulation
- Medical subject headings
- Stroke, Autonomic Nervous System Diseases, Ischemic Stroke
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2007 (estimated)
- Study startJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular AccidentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Siupak Lee, M.D., Principal investigator, Far Eastern Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00422474
- Sponsor's protocol ID
- FEMH-95-C-012
- Status last verified
- Jul 2008
- First submitted
- 14 Jan 2007
- Last updated
- 10 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00422474
- Acronym / sponsor ID
- FEMH-95-C-012
- Keywords
- Ischemic stroke, Baroreflex sensitivity, Prognosis, Cardiovascular autonomic regulation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- Jan 2007
- First posted
- 17 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- NIHSS score > 10
- Patient could not cooperate
- Unstable vital sign
- Atrial fibrillation
- Transient ischemic attack patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Siupak Lee, M.D. contact
Siupak Lee, M.D. principal investigator
Far Eastern Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cerebrovascular Accident and Baroreflexes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Siupak Lee, M.D. (siupakmd@ms1.hinet.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2008.