Cerebrovascular AccidentNCT02358252
Heart Rate Variability and Orthostatic Hypotension in Stroke Patients Evaluated by Intelligent Biosensor System
An observational study of Cerebrovascular Accident, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
This research investigated the heart rate variability (HRV) and stroke patients' orthostatic hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting angle controlled by tilting table with intelligent biosensor. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Cerebrovascular Accident
- How many people
- 0 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2014to 22 Jan 2020
- 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 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: stroke patients
Who may be able to join
- Patients who are first time to get stroke.
Who cannot join
- unstable physiological conditions, serious joint spasticity, use cortisol or calming drugs, other neurological diseases
Trial locations and contacts
1 site in 1 country.
About this study
This research investigated the heart rate variability (HRV) and stroke patients' orthostatic hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting angle controlled by tilting table with intelligent biosensor.
Read the detailed description
Stroke patients readily accompany with the occurrence of orthostatic hypotension. To earlier predict patients occurring dizziness during the tilt table test, this study utilized a self-developed integrated intelligent biosensor system to assist clinical staff efficiently and immediately assessing stroke patients with orthostatic hypotension. Further purposes were to survey the relationship between the orthostatic hypotension and heart rate variability (HRV) and find the predicted models of orthostatic hypotension.
- Conditions
- Cerebrovascular Accident
- Keywords
- Heart Rate Variability, orthostatic hypotension, stroke, integrated intelligent biosensor system
- Medical subject headings
- Stroke, Hypotension, Orthostatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Orthostatic hypotension | Collection of information of body mass index, modified Ashworth scale, maximal voluntary contraction(MVC), heart rate variability(HRV). Tilt table test was used in this study to identify if the subjects with or without orthostatic hypotension. | |
| Non-orthostatic hypotension | Collection of information of body mass index, modified Ashworth scale, maximal voluntary contraction(MVC), heart rate variability(HRV) Tilt table test was used in this study to identify if the subjects with or without orthostatic hypotension. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Heart Rate Variability (HRV)
measure subject's HRV, every 3 mins during the Tilt table test
Measured: Baseline: before Tilt table test, resting position, measure HRV with 3 minutes interval, totally 7 HRVs were measured
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJan 2014
- Primary completion22 Dec 2019
- Study completion22 Jan 2020
Why it stopped: The device was under developed with some technical bugs.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ta-Sen Wei,MD, Changhua Christian Hospital
- Investigators
- TaSen Wei, Principal investigator, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02358252
- Sponsor's protocol ID
- CCH-140103
- Status last verified
- Jan 2020
- First submitted
- 28 Jan 2015
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Variability and Orthostatic Hypotension in Stroke Patients Evaluated by Intelligent Biosensor System
- ClinicalTrials.gov ID
- NCT02358252
- Acronym / sponsor ID
- CCH-140103
- Conditions
- Cerebrovascular Accident
- Keywords
- Heart Rate Variability, orthostatic hypotension, stroke, integrated intelligent biosensor system
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The device was under developed with some technical bugs.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- 22 Dec 2019 (actual)
- Study completion
- 22 Jan 2020 (actual)
- First posted
- 6 Feb 2015 (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.
This research investigated the heart rate variability (HRV) and stroke patients' orthostatic hypotension in hospitalized stroke patients accompanied with dizziness at varied tilting angle controlled by tilting table with intelligent biosensor.
Detailed description
Stroke patients readily accompany with the occurrence of orthostatic hypotension. To earlier predict patients occurring dizziness during the tilt table test, this study utilized a self-developed integrated intelligent biosensor system to assist clinical staff efficiently and immediately assessing stroke patients with orthostatic hypotension. Further purposes were to survey the relationship between the orthostatic hypotension and heart rate variability (HRV) and find the predicted models of orthostatic hypotension.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orthostatic hypotension | – | –Collection of information of body mass index, modified Ashworth scale, maximal voluntary contraction(MVC), heart rate variability(HRV). Tilt table test was used in this study to identify if the subjects with or without orthostatic hypotension. |
| Non-orthostatic hypotension | – | –Collection of information of body mass index, modified Ashworth scale, maximal voluntary contraction(MVC), heart rate variability(HRV) Tilt table test was used in this study to identify if the subjects with or without orthostatic hypotension. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- stroke patients
Key inclusion criteria (1 listed)
- Patients who are first time to get stroke.
Key exclusion criteria (1 listed)
- unstable physiological conditions, serious joint spasticity, use cortisol or calming drugs, other neurological diseases
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
Change of Heart Rate Variability (HRV)
Time frame: Baseline: before Tilt table test, resting position, measure HRV with 3 minutes interval, totally 7 HRVs were measured
measure subject's HRV, every 3 mins during the Tilt table test
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
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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.
TaSen Wei principal investigator
Changhua Christian 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, run by Changhua Christian 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 31 Jan 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Heart Rate Variability (HRV) (time frame: Baseline: before Tilt table test, resting position, measure HRV with 3 minutes interval, totally 7 HRVs were measured). It is what the study was designed to measure, not a finding.
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 31 Jan 2020.