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

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ClinicalTrials.gov Identifier: NCT00606736
Recruitment Status : Withdrawn (it's difficult to recruit enough participants eligible for this study)
First Posted : February 4, 2008
Last Update Posted : July 3, 2015
Sponsor:
Information provided by:
Harbin Medical University

Study Description
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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

Condition or disease
Ventricular Premature Complexes

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.
Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle
Study Start Date : January 2008
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Groups and Cohorts
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Group/Cohort
patients
subjects with right ventricular outflow tract arrhythmia
control
subjects ,age match,healthy


Outcome Measures
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Primary Outcome Measures :
  1. number and duration of right ventricular outflow tract arrhythmia [ Time Frame: one month ]

Secondary Outcome Measures :
  1. sex hormone levels [ Time Frame: one month ]

Biospecimen Retention:   Samples With DNA
whole blood, serum

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women aged 20 to 45 years with regular menstrual cycles.
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
Contacts and Locations
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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): NCT00606736


Locations
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China, Heilongjiang
Cardiology Department of the 4Th Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150001
Sponsors and Collaborators
Harbin Medical University
Investigators
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Study Director: Xueqi Li, doctor the fourth hospital of harbin medical university
More Information
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Responsible Party: Bai Xiaopeng, Vasculocardiology Deparment ,The Fourth Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT00606736    
Other Study ID Numbers: HMU-007
HMU-008
First Posted: February 4, 2008    Key Record Dates
Last Update Posted: July 3, 2015
Last Verified: January 2008
Keywords provided by Harbin Medical University:
right ventricular outflow tract arrhythmia
sex hormone level
menstrual cycle
Gonadal Hormones
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Ventricular Premature Complexes
Heart Diseases
Cardiovascular Diseases
 Pathologic Processes
Cardiac Complexes, Premature
Cardiac Conduction System Disease