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Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
Taipei Medical University WanFang Hospital
Information provided by:
Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01136343
First received: May 31, 2010
Last updated: December 1, 2010
Last verified: December 2010
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Purpose
In Taiwan, heart disease and cerebrovascular disease ranked the second and third of ten leading causes of death in female in 2007; half of these deaths is due to coronary artery disease (CAD). Postmenopausal status is an independent risk factor for CAD. Early assessment and proper management of risk factors may reduce the prevalence rate of CAD. In the past decade, despite increased attention to CAD in women, most studies focused on certain menopausal status instead of all phases of menopause or on risk factors limited to related metabolic syndrome. Because the prevalence of risk factors related to CAD is influenced by various physiological and lifestyle status in different menopausal statuses, the purpose of this study, at the first stage, is to explore respectively the risk factors of CAD among middle-aged women in three menopausal statuses. At the second stage, the influence of a lifestyle management program on risk factors modification among pre-menopausal women is examined in this study.
| Condition | Intervention |
|---|---|
| Coronary Artery Disease | Other: lifestyle modified project |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Comparison of Predictive Factors Related to Coronary Artery Disease Among Different Menopausal Status and Effect of a Life Style Management Program on Risk Factors Modification Among Middle-aged Women |
Resource links provided by NLM:
Further study details as provided by Taipei Medical University WanFang Hospital:
Primary Outcome Measures:
- lifestylephysical activity, dietary, depression, anxiety
Secondary Outcome Measures:
- metabolic [ Time Frame: 6 months ]blood pressure, lipid profile, blood sugar, obesity
- biomarkershsCRP, homocysteine, leptin
| Estimated Enrollment: | 130 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | August 2012 |
| Estimated Primary Completion Date: | August 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: lifestyle modified project
education, counseling
|
Other: lifestyle modified project
education, counseling
|
|
No Intervention: control
waiting list control
|
Eligibility| Ages Eligible for Study: | 40 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diagnosis of CAD by coroangiography
- LVEF >30%
Exclusion Criteria:
- impairment of physical activity
- history of psychiatric disorder, vital arrhythmia
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01136343
Please refer to this study by its ClinicalTrials.gov identifier: NCT01136343
Contacts
| Contact: Chii Jeng | 886-2-27361661 ext 6305 | chii@tmu.edu.tw |
Locations
| Taiwan | |
| Wan Fang Hospital | Recruiting |
| Taipei, Taiwan | |
| Principal Investigator: Jeng Chii | |
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
| Principal Investigator: | Chii Jeng | Taipei Medical University College of Nursing |
More Information
| Responsible Party: | Jeng Chii, Taipei Medical University / College of Nursing |
| ClinicalTrials.gov Identifier: | NCT01136343 History of Changes |
| Other Study ID Numbers: |
99001 |
| Study First Received: | May 31, 2010 |
| Last Updated: | December 1, 2010 |
Keywords provided by Taipei Medical University WanFang Hospital:
|
women middle age risk factor |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases |
Cardiovascular Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on June 27, 2017