Ventricular Premature ComplexesNCT00606736
Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle
An observational study of Ventricular Premature Complexes, run by Harbin Medical University at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Ventricular Premature Complexes
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Jan 2008to Dec 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women aged 20 to 45 years with regular menstrual cycles.
Who may be able to join
- 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.
Who cannot join
- Pregnancy
- Use of hormonal therapy including birth control pills or other drugs
Trial locations and contacts
1 site in 1 country.
China1 site
Cardiology Department of the 4Th Hospital of Harbin Medical University
Harbin, Heilongjiang, 150001
About this study
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
Read the 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.
- Conditions
- Ventricular Premature Complexes
- Keywords
- right ventricular outflow tract arrhythmia, sex hormone level, menstrual cycle, Gonadal Hormones
- Medical subject headings
- Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | subjects with right ventricular outflow tract arrhythmia | |
| control | subjects ,age match,healthy |
What is being measured
The primary outcome is the main question the study is designed to answer.
number and duration of right ventricular outflow tract arrhythmia
Measured: one month
Secondary outcomes (1)
sex hormone levels
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionDec 2008
- Study completionDec 2008
Why it stopped: it's difficult to recruit enough participants eligible for this study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Premature ComplexesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harbin Medical University
- Sponsor type
- University, hospital or other
- Investigators
- Xueqi Li, doctor, Study director, the fourth hospital of harbin medical university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00606736
- Sponsor's protocol ID
- HMU-007
- Other IDs
- HMU-008
- Status last verified
- Jan 2008
- First submitted
- 22 Jan 2008
- Last updated
- 3 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relativity Study Between Idiopathic Ventricular Arrhythmia and Sex Hormone Levels in Different Stages of Menstrual Cycle
- ClinicalTrials.gov ID
- NCT00606736
- Acronym / sponsor ID
- HMU-007
- Conditions
- Ventricular Premature Complexes
- Keywords
- right ventricular outflow tract arrhythmia, sex hormone level, menstrual cycle, Gonadal Hormones
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: it's difficult to recruit enough participants eligible for this study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Harbin Medical UniversityUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –subjects with right ventricular outflow tract arrhythmia |
| control | – | –subjects ,age match,healthy |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women aged 20 to 45 years with regular menstrual cycles.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnancy
- Use of hormonal therapy including birth control pills or other drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number and duration of right ventricular outflow tract arrhythmia
Time frame: one month
1 secondary outcome
sex hormone levels
Time frame: one month
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xueqi Li, doctor study director
the fourth hospital of harbin medical university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Premature Complexes, run by Harbin Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number and duration of right ventricular outflow tract arrhythmia (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2015.