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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by Harbin Medical University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Harbin Medical University
ClinicalTrials.gov Identifier:
NCT00606736
First received: January 22, 2008
Last updated: February 1, 2008
Last verified: January 2008
History of Changes
  Purpose

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
Ventricular Premature Complexes

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harbin Medical University:

Primary Outcome Measures:
  • number and duration of right ventricular outflow tract arrhythmia [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • sex hormone levels [ Time Frame: one month ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

whole blood, serum


Estimated Enrollment: 40
Study Start Date: January 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients
subjects with right ventricular outflow tract arrhythmia
control
subjects ,age match,healthy

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.

  Eligibility

Ages Eligible for Study:   20 Years to 45 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606736

Contacts
Contact: Xiaopeng Bai, doctor 0086-0451-84028663 bxp007@163.com
Contact: Xueqi Li, doctor 0086-0451-82576775 lixueqi@medmail.com.cn

Locations
China, Heilongjiang
Cardiology Department of the 4Th Hospital of Harbin Medical University Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Xiaopeng Bai, doctor     0086-0451-84028663     bxp007@163.com    
Contact: Xueqi Li, doctor     0086-0451-82576775     lixueqi@medmail.com.cn    
Sub-Investigator: lingqi Zhou, master            
Principal Investigator: Xiaopeng Bai, doctor            
Sponsors and Collaborators
Harbin Medical University
Investigators
Study Director: Xueqi Li, doctor the fourth hospital of harbin medical university
  More Information

No publications provided

Responsible Party: Bai Xiaopeng, Vasculocardiology Deparment ,The Fourth Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT00606736     History of Changes
Other Study ID Numbers: HMU-007, HMU-008
Study First Received: January 22, 2008
Last Updated: February 1, 2008
Health Authority: China: Ethics Committee

Keywords provided by Harbin Medical University:
right ventricular outflow tract arrhythmia
sex hormone level
menstrual cycle
Gonadal Hormones

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Ventricular Premature Complexes
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
 Cardiac Complexes, Premature
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013