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Correlation Between Epistaxis and Cardiovascular Disease (CBECD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02677467
Recruitment Status : Unknown
Verified February 2016 by LEE YOON-JE, Hanyang University.
Recruitment status was:  Not yet recruiting
First Posted : February 9, 2016
Last Update Posted : February 9, 2016
Sponsor:
Information provided by (Responsible Party):
LEE YOON-JE, Hanyang University

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
Cardiovascular Disease Epistaxis 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Epistaxis Correlate With Cardiovascular Disease?
Study Start Date : March 2016
Estimated Primary Completion Date : June 2016
Estimated Study Completion Date : August 2016

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




Primary Outcome Measures :
  1. Cholesterol level in each group [ Time Frame: 1 day ]
  2. BP variability level in each group [ Time Frame: 1 day ]
  3. Pulse wave velocity in each group [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Smoking History in each group [ Time Frame: 1 day ]
    Example = "12 pack-year"

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

Biospecimen Retention:   Samples Without DNA
Blood sample for evaluating about cardiovasular risk.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02677467


Contacts
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Contact: YOONJE LEE, M.D. +82-31_560-2053 yong0831@naver.com
Contact: CHANGSUN KIM, M.D., Ph.D. +82-31-560-2057 flyes98@naver.com

Locations
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Korea, Republic of
Hanyang University Guri Hospital
Guri-si, Gyeonggi-do, Korea, Republic of, 471-701
Contact: YOONJE LEE, M.D.    +82-31-560-2053    yong0831@naver.com   
Principal Investigator: YOONJE LEE, M.D.         
Sponsors and Collaborators
Hanyang University
Investigators
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Study Chair: JUNGHOON SHIN, M.D., Ph.D. Hanyang University
Additional Information:

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Responsible Party: LEE YOON-JE, Fellowship, Emergency Medincine, Hanyang University
ClinicalTrials.gov Identifier: NCT02677467    
Other Study ID Numbers: Gurivengers
First Posted: February 9, 2016    Key Record Dates
Last Update Posted: February 9, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: The investigators make a registry for individual participant data and collect the registry and share it.
Additional relevant MeSH terms:
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Epistaxis
Cardiovascular Diseases
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Hemorrhage
Pathologic Processes
Signs and Symptoms, Respiratory