Correlation Between Epistaxis and Cardiovascular Disease (CBECD)

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.

Study Overview

• Status: Unknown
• Conditions: Cardiovascular Disease; Epistaxis
• Intervention / Treatment: Biological: Blood-pressure variability

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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: YOONJE LEE, M.D.; Phone Number: +82-31_560-2053; Email: yong0831@naver.com
• Study Contact Backup: Name: CHANGSUN KIM, M.D., Ph.D.; Phone Number: +82-31-560-2057; Email: flyes98@naver.com

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
      • Hanyang University Guri Hospital
      • Contact: YOONJE LEE, M.D.; Phone Number: +82-31-560-2053; Email: yong0831@naver.com
      • Principal Investigator: YOONJE LEE, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Biological: Blood-pressure variability; Day to Night 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.	Biological: Blood-pressure variability; Day to Night Blood pressure variability

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cholesterol level in each group	1 day
BP variability level in each group	1 day
Pulse wave velocity in each group	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking History in each group	Example = "12 pack-year"	1 day
Body Mass Index in each group		1 day

Collaborators and Investigators

• Sponsor: Hanyang University
• Investigators: Study Chair: JUNGHOON SHIN, M.D., Ph.D., Hanyang University

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Anticipated): June 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: January 31, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Hemorrhage; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Nose Diseases; Cardiovascular Diseases; Epistaxis
• Other Study ID Numbers: Gurivengers

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators make a registry for individual participant data and collect the registry and share it.