Relativity Study Between Idiopathic Ventricular Arrhythmi... | NCT00606736

Studies
Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle

NCT00606736

Sponsor

Harbin Medical University

Status

Withdrawn

Last Update Posted

Jul 3, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Ventricular Premature Complexes

Interventions

Not provided

Countries

China

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

ID	Type	Description	Link
HMU-008

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

it's difficult to recruit enough participants eligible for this study

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2008Actual

First Submitted Date

Jan 22, 2008

First Submission Date that Met QC Criteria

Feb 1, 2008

First Posted Date

Feb 4, 2008Estimated

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

Jul 2, 2015

Last Update Posted Date

Jul 3, 2015Estimated

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

The purpose of this study is to determine whether the occurrence of idiopathic right ventricular outflow tract(RVOT) arrhythmia is relative to sex hormone levels in different stages of female menstrual cycle

Detailed Description

The predilection site of idiopathic ventricular arrhythmia is right ventricular outflow tract ,which is called idiopathic RVOT arrhythmia , a retrospective study reported the females are susceptibility to this kind of arrhythmia and another questionaire survey of triggers for RVOT-VT initiation indicated that women have RVOT-A initiation with recognized states of sex hormonal flux , but few researches were made to study the exact relation between this kind of arrhythmia and sex hormone levels, this is the aim of our study .40 females with regular menses(20 females with RVOT arrhythmia ,20 healthy volunteers) will be screened, the Participants will undergo ECG monitoring and their blood samples will be collected at various times throughout the study.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
patients		subjects with right ventricular outflow tract arrhythmia
control		subjects ,age match,healthy

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number and duration of right ventricular outflow tract arrhythmia		one month

Secondary Outcomes

Measure	Description	Time Frame
sex hormone levels		one month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Must be female
Aged 20 to 45 years, with regular menstrual cycles.
With normal BMI
Without organic heart disease
Healthy volunteers and women with RVOT arrhythmia are both being recruited.

Exclusion Criteria:

Pregnancy
Use of hormonal therapy including birth control pills or other drugs

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Women aged 20 to 45 years with regular menstrual cycles.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Xueqi Li, doctor	the fourth hospital of harbin medical university	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cardiology Department of the 4Th Hospital of Harbin Medical University		Harbin	Heilongjiang	150001	China

Condition Browse Module

MeSH Terms

ID	Term
D018879	Ventricular Premature Complexes

Ancestor Terms

ID	Term
D005117	Cardiac Complexes, Premature
D001145	Arrhythmias, Cardiac
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided