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 because the information has not been verified recently.
Verified December 2010 by Taipei Medical University WanFang Hospital.
Recruitment status was  Recruiting
Sponsor:
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
  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
Endpoint Classification: Efficacy Study
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:
  • lifestyle [ Designated as safety issue: No ]
    physical activity, dietary, depression, anxiety


Secondary Outcome Measures:
  • metabolic [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    blood pressure, lipid profile, blood sugar, obesity

  • biomarkers [ Designated as safety issue: No ]
    hsCRP, 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
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Health Authority: Taiwan: Department of Health

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 September 18, 2014