CBECD: Correlation Between Epistaxis and Cardiovascular Disease

Sponsor
Hanyang University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02677467
Collaborator
(none)
50
1
5
9.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
50 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Epistaxis Correlate With Cardiovascular Disease?
Study Start Date :
Mar 1, 2016
Anticipated Primary Completion Date :
Jun 1, 2016
Anticipated Study Completion Date :
Aug 1, 2016

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cholesterol level in each group [1 day]

  2. BP variability level in each group [1 day]

  3. Pulse wave velocity in each group [1 day]

Secondary Outcome Measures

  1. Smoking History in each group [1 day]

    Example = "12 pack-year"

  2. Body Mass Index in each group [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hanyang University Guri Hospital Guri-si Gyeonggi-do Korea, Republic of 471-701

Sponsors and Collaborators

  • Hanyang University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
LEE YOON-JE, Fellowship, Emergency Medincine, Hanyang University
ClinicalTrials.gov Identifier:
NCT02677467
Other Study ID Numbers:
  • Gurivengers
First Posted:
Feb 9, 2016
Last Update Posted:
Feb 9, 2016
Last Verified:
Feb 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 9, 2016