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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

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ClinicalTrials.gov Identifier: NCT01136343
Recruitment Status : Unknown
Verified December 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was:  Recruiting
First Posted : June 3, 2010
Last Update Posted : December 3, 2010
Sponsor:
Information provided by:
Taipei Medical University WanFang Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Coronary Artery Disease Other: lifestyle modified project Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : February 2010
Estimated Primary Completion Date : August 2012
Estimated Study Completion Date : August 2012

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: lifestyle modified project
education, counseling
 Other: lifestyle modified project
education, counseling
No Intervention: control
waiting list control


Outcome Measures
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Primary Outcome Measures :
  1. lifestyle
    physical activity, dietary, depression, anxiety


Secondary Outcome Measures :
  1. metabolic [ Time Frame: 6 months ]
    blood pressure, lipid profile, blood sugar, obesity

  2. biomarkers
    hsCRP, homocysteine, leptin


Eligibility Criteria
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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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Jeng Chii, Taipei Medical University / College of Nursing
ClinicalTrials.gov Identifier: NCT01136343     History of Changes
Other Study ID Numbers: 99001
First Posted: June 3, 2010    Key Record Dates
Last Update Posted: December 3, 2010
Last Verified: December 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