Cardiovascular DiseaseCBECDNCT02677467
Correlation Between Epistaxis and Cardiovascular Disease
An observational study of Cardiovascular Disease and Epistaxis, run by Hanyang University at 1 site in South Korea.
Trial summary
Investigators examine blood-pressure variance, several cardiovascular risk factors of patient with epistaxis. As a result of collected data, investigators look into correlation between epistaxis and hypertensive cardiovascular disorder. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Epistaxis
- What is being tested?
- Blood-pressure variability
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2016to Aug 2016
- How long will I take part?
- 3 Months
- 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: Group A : A participant enroll if their age is over 18 with spontaneous epistaxis and their cause of visiting ER is spontaneous epistaxis. Exclusion criteria is that they needs immediately treatment for hypertensive urgency. And, they don't want to participate in this investigation. Group B : A participant enroll if their age is over 18 with bleeding of wound and their cause of visiting ER is to bleed on wound. Exclusion criteria is that their wounds' condition is serious or their pain is much severe. And, they don't want to participate in this investigation.
Who may be able to join
- age is over 18 with spontaneous epistaxis
- age is over 18 with bleeding of wound
Who cannot join
- they needs immediately treatment for hypertensive urgency.
- they don't want to participate in this investigation.
- Group B
- their wounds' condition is serious or their pain is much severe.
- they don't want to participate in this investigation.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, 471-701
YOONJE LEE, M.D., +82-31-560-2053, yong0831@naver.com
YOONJE LEE, M.D.
About this study
Official title: Epistaxis Correlate With Cardiovascular Disease?
Investigators examine blood-pressure variance, several cardiovascular risk factors of patient with epistaxis. As a result of collected data, investigators look into correlation between epistaxis and hypertensive cardiovascular disorder.
Read the detailed description
This study is prospective observational single blinded study.
A participant is visit in the ER who patient with epistaxis.
Investigators will enroll 50 patients with epistaxis. Exclusion criteria is that patient needs immediately treatment for hypertensive urgency or patient with nasal trauma.
Investigators examine blood-pressure (BP) at five times in Emergency Department (ED) and out-patient department (opd) of Otorhinolaryngology (OL) . Investigators explain this study and ask to write consent for participant. After proper management of epistaxis, investigators get blood sampling of the participant and, the participant has a reservation to "opd of cardiovascular division of Internal Medicine" (CV opd) in the hospital.
When the participant visit CV opd, the participant undergo 24-hours-BP-monitoring and Pulse wave velocity (PWV).
After that, the participant will be follow-up for 3 months.
Investigators collect 50 data from 50 participants as a registry and analyze the data.
- Conditions
- Cardiovascular Disease, Epistaxis
- Being tested
- Blood-pressure variability
- Medical subject headings
- Cardiovascular Diseases, Epistaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood-pressure variabilityBiological
Day to Night Blood pressure variability
| Study group | Role | What they receive |
|---|---|---|
| Spontaneous epistaxis | A participant enroll if their age is over 18 with spontaneous epistaxis and their cause of visiting ER is spontaneous epistaxis. Exclusion criteria is that they needs immediately treatment for hypertensive urgency. And, they don't want to participate in this investigation. Investigators examine their blood-pressure variability and cardiovascular risk throughout their blood sample analysis. Receives: Biological: Blood-pressure variability | |
| Bleeding of wound | A participant enroll if their age is over 18 with bleeding of wound and their cause of visiting ER is to bleed on wound. Exclusion criteria is that their wounds' condition is serious or their pain is much severe. And, they don't want to participate in this investigation. Investigators examine their blood-pressure variability and cardiovascular risk throughout their blood sample analysis. Receives: Biological: Blood-pressure variability |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cholesterol level in each group
Measured: 1 day
BP variability level in each group
Measured: 1 day
Pulse wave velocity in each group
Measured: 1 day
Secondary outcomes (2)
Smoking History in each group
Example = "12 pack-year"
Measured: 1 day
Body Mass Index in each group
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJun 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseaseStudies 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
- 50 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hanyang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LEE YOON-JE, Hanyang University
- Investigators
- JUNGHOON SHIN, M.D., Ph.D., Study chair, Hanyang University Guri Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02677467
- Sponsor's protocol ID
- Gurivengers
- Acronym
- CBECD
- Status last verified
- Feb 2016
- First submitted
- 31 Jan 2016
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: The investigators make a registry for individual participant data and collect the registry and share it.
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epistaxis Correlate With Cardiovascular Disease?
- ClinicalTrials.gov ID
- NCT02677467
- Acronym / sponsor ID
- CBECD / Gurivengers
- Conditions
- Cardiovascular Disease, Epistaxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hanyang UniversityUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 9 Feb 2016 (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.
Investigators examine blood-pressure variance, several cardiovascular risk factors of patient with epistaxis. As a result of collected data, investigators look into correlation between epistaxis and hypertensive cardiovascular disorder.
Detailed description
This study is prospective observational single blinded study.
A participant is visit in the ER who patient with epistaxis.
Investigators will enroll 50 patients with epistaxis. Exclusion criteria is that patient needs immediately treatment for hypertensive urgency or patient with nasal trauma.
Investigators examine blood-pressure (BP) at five times in Emergency Department (ED) and out-patient department (opd) of Otorhinolaryngology (OL) . Investigators explain this study and ask to write consent for participant. After proper management of epistaxis, investigators get blood sampling of the participant and, the participant has a reservation to "opd of cardiovascular division of Internal Medicine" (CV opd) in the hospital.
When the participant visit CV opd, the participant undergo 24-hours-BP-monitoring and Pulse wave velocity (PWV).
After that, the participant will be follow-up for 3 months.
Investigators collect 50 data from 50 participants as a registry and analyze the data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spontaneous epistaxis | – | Biological: Blood-pressure variabilityA participant enroll if their age is over 18 with spontaneous epistaxis and their cause of visiting ER is spontaneous epistaxis. Exclusion criteria is that they needs immediately treatment for hypertensive urgency. And, they don't want to participate in this investigation. Investigators examine their blood-pressure variability and cardiovascular risk throughout their blood sample analysis. |
| Bleeding of wound | – | Biological: Blood-pressure variabilityA participant enroll if their age is over 18 with bleeding of wound and their cause of visiting ER is to bleed on wound. Exclusion criteria is that their wounds' condition is serious or their pain is much severe. And, they don't want to participate in this investigation. Investigators examine their blood-pressure variability and cardiovascular risk throughout their blood sample analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Group A : A participant enroll if their age is over 18 with spontaneous epistaxis and their cause of visiting ER is spontaneous epistaxis. Exclusion criteria is that they needs immediately treatment for hypertensive urgency. And, they don't want to participate in this investigation. Group B : A participant enroll if their age is over 18 with bleeding of wound and their cause of visiting ER is to bleed on wound. Exclusion criteria is that their wounds' condition is serious or their pain is much severe. And, they don't want to participate in this investigation.
Key inclusion criteria (2 listed)
- age is over 18 with spontaneous epistaxis
- age is over 18 with bleeding of wound
Key exclusion criteria (5 listed)
- they needs immediately treatment for hypertensive urgency.
- they don't want to participate in this investigation.
- Group B
- their wounds' condition is serious or their pain is much severe.
- they don't want to participate in this investigation.
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 |
|---|---|---|
| Blood-pressure variabilityDay to Night Blood pressure variability | Biological | Bleeding of wound, Spontaneous epistaxis |
Primary outcome
Cholesterol level in each group
Time frame: 1 day
BP variability level in each group
Time frame: 1 day
Pulse wave velocity in each group
Time frame: 1 day
2 secondary outcomes
Smoking History in each group
Time frame: 1 day
Body Mass Index in each group
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Individual participant dataSharing planned: Yes. The investigators make a registry for individual participant data and collect the registry and share it.
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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.
JUNGHOON SHIN, M.D., Ph.D. study chair
Hanyang University Guri 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 Cardiovascular Disease and Epistaxis, run by Hanyang University at 1 site in South Korea.
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 5 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 9 Feb 2016. 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 South Korea. 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 YOONJE LEE, M.D. (+82-31_560-2053, yong0831@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cholesterol level in each group (time frame: 1 day). The study lists 3 primary outcomes in all. 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 9 Feb 2016.