search
Back to results

Comparison of Predictive Factors Related to Coronary Artery Disease

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
lifestyle modified project
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Coronary Artery Disease focused on measuring women, middle age, risk factor

Eligibility Criteria

40 Years - 64 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • diagnosis of CAD by coroangiography
  • LVEF >30%

Exclusion Criteria:

  • impairment of physical activity
  • history of psychiatric disorder, vital arrhythmia

Sites / Locations

  • Wan Fang Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

lifestyle modified project

control

Arm Description

education, counseling

waiting list control

Outcomes

Primary Outcome Measures

lifestyle
physical activity, dietary, depression, anxiety

Secondary Outcome Measures

metabolic
blood pressure, lipid profile, blood sugar, obesity
biomarkers
hsCRP, homocysteine, leptin

Full Information

First Posted
May 31, 2010
Last Updated
March 19, 2023
Sponsor
Taipei Medical University WanFang Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01136343
Brief Title
Comparison of Predictive Factors Related to Coronary Artery Disease
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 Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University WanFang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
women, middle age, risk factor

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lifestyle modified project
Arm Type
Experimental
Arm Description
education, counseling
Arm Title
control
Arm Type
No Intervention
Arm Description
waiting list control
Intervention Type
Other
Intervention Name(s)
lifestyle modified project
Intervention Description
education, counseling
Primary Outcome Measure Information:
Title
lifestyle
Description
physical activity, dietary, depression, anxiety
Secondary Outcome Measure Information:
Title
metabolic
Description
blood pressure, lipid profile, blood sugar, obesity
Time Frame
6 months
Title
biomarkers
Description
hsCRP, homocysteine, leptin

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosis of CAD by coroangiography LVEF >30% Exclusion Criteria: impairment of physical activity history of psychiatric disorder, vital arrhythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chii Jeng
Organizational Affiliation
Taipei Medical University College of Nursing
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wan Fang Hospital
City
Taipei
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Comparison of Predictive Factors Related to Coronary Artery Disease

We'll reach out to this number within 24 hrs