EpistaxisNCT03092973
Carotid Intima Media Thickness (CIMT) in Epistaxis
An observational study of Epistaxis and Atherosclerosis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Epistaxis is a very frequent emergency among adults and often needs specialised treatment in an ENT-department. Among others, atherosclerosis is often named as a reason for an increased risk for Epistaxis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epistaxis, Atherosclerosis
- What is being tested?
- Ultrasound
- How many people
- 82 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2016to 30 Jun 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 50 patients with epistaxis and 50 healthy controls.
Who may be able to join
- active or very recently active anterior or posterior epistaxis
- at least 18 years old
Who cannot join
- posttraumatic or postoperative epistaxis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital of Zurich
Zurich, Canton of Zurich, 8091
About this study
Official title: Carotid Intima Media Thickness in Patients With Epistaxis: a Surrogate Marker for Generalised Atherosclerosis
Epistaxis is a very frequent emergency among adults and often needs specialised treatment in an ENT-department. Among others, atherosclerosis is often named as a reason for an increased risk for Epistaxis. To evaluate whether or not this is the case, the investigators examined the carotid intima media thickness via ultrasound in patients who were treated in the ENT-department of the University Hospital of Zurich.
- Conditions
- Epistaxis, Atherosclerosis
- Being tested
- Ultrasound
- Medical subject headings
- Epistaxis, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Epistaxis Group | Not described Receives: Diagnostic Test: Ultrasound | |
| Control Group | Not described Receives: Diagnostic Test: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Carotid Intima Media Thickness in Epistaxis vs. Controls
Measured: June 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start1 Dec 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EpistaxisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Soyka, PD Dr. med., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03092973
- Sponsor's protocol ID
- CIMT in Epistaxis
- Status last verified
- Oct 2017
- First submitted
- 22 Mar 2017
- Last updated
- 30 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The participant data will no longer be used by us or other researchers after the project is finished.
Publications
Kunz SM, Holzmann D, Soyka MB. Association of epistaxis with atherosclerotic cardiovascular disease. Laryngoscope. 2019 Apr;129(4):783-787. doi: 10.1002/lary.27604. Epub 2018 Dec 13.
PubMed 30549051
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Intima Media Thickness in Patients With Epistaxis: a Surrogate Marker for Generalised Atherosclerosis
- ClinicalTrials.gov ID
- NCT03092973
- Acronym / sponsor ID
- CIMT in Epistaxis
- Conditions
- Epistaxis, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 28 Mar 2017 (actual)
- 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.
Epistaxis is a very frequent emergency among adults and often needs specialised treatment in an ENT-department. Among others, atherosclerosis is often named as a reason for an increased risk for Epistaxis. To evaluate whether or not this is the case, the investigators examined the carotid intima media thickness via ultrasound in patients who were treated in the ENT-department of the University Hospital of Zurich.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epistaxis Group | – | Diagnostic Test: Ultrasound |
| Control Group | – | Diagnostic Test: Ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50 patients with epistaxis and 50 healthy controls.
Key inclusion criteria (2 listed)
- active or very recently active anterior or posterior epistaxis
- at least 18 years old
Key exclusion criteria (1 listed)
- posttraumatic or postoperative epistaxis
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 |
|---|---|---|
| Ultrasound | Diagnostic test | Control Group, Epistaxis Group |
Primary outcome
Carotid Intima Media Thickness in Epistaxis vs. Controls
Time frame: June 2017
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 30 Oct 2017.
- Derived from this study: PubMed 30549051Kunz SM, Holzmann D, Soyka MB. Association of epistaxis with atherosclerotic cardiovascular disease. Laryngoscope. 2019 Apr;129(4):783-787. doi: 10.1002/lary.27604. Epub 2018 Dec 13.
- Individual participant dataSharing planned: No. The participant data will no longer be used by us or other researchers after the project is finished.
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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.
Michael Soyka, PD Dr. med. principal investigator
University of Zurich
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 Epistaxis and Atherosclerosis, run by University of Zurich at 1 site in Switzerland.
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 2 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: finished, as of the sponsor's last update on 30 Oct 2017. 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 Switzerland. 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?
Carotid Intima Media Thickness in Epistaxis vs. Controls (time frame: June 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03092973, which also lists 1 linked publication.
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 30 Oct 2017.