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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02677467
Other study ID # Gurivengers
Secondary ID
Status Not yet recruiting
Phase N/A
First received January 31, 2016
Last updated February 8, 2016
Start date March 2016
Est. completion date August 2016

Study information

Verified date February 2016
Source Hanyang University
Contact YOONJE LEE, M.D.
Phone +82-31_560-2053
Email yong0831@naver.com
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date August 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Group A

Inclusion Criteria:

- age is over 18 with spontaneous epistaxis

Exclusion Criteria:

- they needs immediately treatment for hypertensive urgency.

- they don't want to participate in this investigation.

Group B

Inclusion Criteria:

- age is over 18 with bleeding of wound

Exclusion Criteria:

- their wounds' condition is serious or their pain is much severe.

- they don't want to participate in this investigation.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Biological:
Blood-pressure variability
Day to Night Blood pressure variability

Locations

Country Name City State
Korea, Republic of Hanyang University Guri Hospital Guri-si Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Hanyang University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Cholesterol level in each group 1 day Yes
Primary BP variability level in each group 1 day Yes
Primary Pulse wave velocity in each group 1 day Yes
Secondary Smoking History in each group Example = "12 pack-year" 1 day Yes
Secondary Body Mass Index in each group 1 day Yes
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