Correlation Between Epistaxis and Cardiovascular Disease | NCT02677467

Studies
Correlation Between Epistaxis and Cardiovascular Disease

NCT02677467

Sponsor

Hanyang University

Status

Unknown status

Last Update Posted

Feb 9, 2016Estimated

Enrollment

50Estimated

Phase

Not provided

Conditions

Cardiovascular Disease
Epistaxis

Interventions

Blood-pressure variability

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Jun 2016Estimated

Completion Date

Aug 2016Estimated

First Submitted Date

Jan 31, 2016

First Submission Date that Met QC Criteria

Feb 8, 2016

First Posted Date

Feb 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 8, 2016

Last Update Posted Date

Feb 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood-pressure variability	Biological	Day to Night Blood pressure variability	Bleeding of wound Spontaneous epistaxis

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder 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.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
YOONJE LEE, M.D.	Contact	+82-31_560-2053		yong0831@naver.com
CHANGSUN KIM, M.D., Ph.D.	Contact	+82-31-560-2057		flyes98@naver.com

Overall Officials

Name	Affiliation	Role
JUNGHOON SHIN, M.D., Ph.D.	Hanyang University Guri Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hanyang University Guri Hospital		Guri-si	Gyeonggi-do	471-701	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

The investigators make a registry for individual participant data and collect the registry and share it.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases
D004844	Epistaxis

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D010038	Otorhinolaryngologic Diseases
D006470	Hemorrhage

Browse Leaves

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Browse Branches

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