NCT00606736

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2008

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

July 3, 2015

Status Verified

January 1, 2008

Enrollment Period

11 months

First QC Date

January 22, 2008

Last Update Submit

July 2, 2015

Conditions

Ventricular Premature Complexes

Keywords

right ventricular outflow tract arrhythmiasex hormone levelmenstrual cycleGonadal Hormones

Outcome Measures

Primary Outcomes (1)

  • number and duration of right ventricular outflow tract arrhythmia

    one month

Secondary Outcomes (1)

  • sex hormone levels

    one month

Study Arms (2)

patients

subjects with right ventricular outflow tract arrhythmia

control

subjects ,age match,healthy

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women aged 20 to 45 years with regular menstrual cycles.

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiology Department of the 4Th Hospital of Harbin Medical University

Harbin, Heilongjiang, 150001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum

MeSH Terms

Conditions

Ventricular Premature Complexes

Condition Hierarchy (Ancestors)

Cardiac Complexes, PrematureArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Xueqi Li, doctor

    the fourth hospital of harbin medical university

    STUDY DIRECTOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 22, 2008

First Posted

February 4, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

July 3, 2015

Record last verified: 2008-01

Locations

CN(1)