SyncopeNCT01831297
Haemodynamic Feasibility Study of Sensors Within a Tilting Table Examination
An observational study of Syncope, run by RWTH Aachen University at 1 site in Germany.
Trial summary
This study´s aim is to explore physiological associations concerning pulse wave velocity, heart rate and blood pressure in order to make taking the blood pressure more comfortable. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Syncope
- What is being tested?
- measurement of blood pressure
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2012to Jul 2013
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with syncope
Who may be able to join
- patients with syncope and planned tilting table investigation
- male and female patients aged at least 18 years
- persons being able to understand and to follow the study stuff´s instructions
Who cannot join
- pregnancy or breast feeding
- patients not being able to consent
- cardiac pacemaker / defibrillator
- illness of skin
Trial locations and contacts
1 site in 1 country.
About this study
This study´s aim is to explore physiological associations concerning pulse wave velocity, heart rate and blood pressure in order to make taking the blood pressure more comfortable.
- Conditions
- Syncope
- Being tested
- measurement of blood pressure
- Medical subject headings
- Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
measurement of blood pressureDevice
measurement of pulse wave velocity
| Study group | Role | What they receive |
|---|---|---|
| syncope | Not described Receives: Device: measurement of blood pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
data about possible correlation
Correlation between pulse wave velocity, pulse rate and blood pressure
Measured: 45 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2013 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SyncopeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01831297
- Sponsor's protocol ID
- 10-082
- Status last verified
- Nov 2013
- First submitted
- 29 Jan 2013
- Last updated
- 27 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Haemodynamic Feasibility Study of Sensors Within a Tilting Table Examination
- ClinicalTrials.gov ID
- NCT01831297
- Acronym / sponsor ID
- 10-082
- Conditions
- Syncope
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Apr 2013 (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 study´s aim is to explore physiological associations concerning pulse wave velocity, heart rate and blood pressure in order to make taking the blood pressure more comfortable.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| syncope | – | Device: measurement of blood pressure |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with syncope
Key inclusion criteria (3 listed)
- patients with syncope and planned tilting table investigation
- male and female patients aged at least 18 years
- persons being able to understand and to follow the study stuff´s instructions
Key exclusion criteria (4 listed)
- pregnancy or breast feeding
- patients not being able to consent
- cardiac pacemaker / defibrillator
- illness of skin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of blood pressuremeasurement of pulse wave velocity | Device | syncope |
Primary outcome
data about possible correlation
Time frame: 45 minutes
Correlation between pulse wave velocity, pulse rate and blood pressure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2013.
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Head-to-Head (H2H) Comparison of Ambulatory Cardiac ECG Monitors in Japan
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Fainting Detection And Early Warning In Syncope Evaluation Study (ARISE)
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Active, not recruiting
Cardioneuroablation for Reflex Syncope and Exercise Capacity
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Syncope, run by RWTH Aachen University at 1 site in Germany.
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 4 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: finished, as of the sponsor's last update on 27 Nov 2013. 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 Germany. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
data about possible correlation (time frame: 45 minutes). 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 27 Nov 2013.