NCT01136343

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Feb 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

March 22, 2023

Status Verified

March 1, 2023

Enrollment Period

2.5 years

First QC Date

May 31, 2010

Last Update Submit

March 19, 2023

Conditions

Coronary Artery Disease

Keywords

womenmiddle agerisk factor

Outcome Measures

Primary Outcomes (1)

  • lifestyle

    physical activity, dietary, depression, anxiety

Secondary Outcomes (2)

  • metabolic

    6 months

  • biomarkers

Study Arms (2)

lifestyle modified project

EXPERIMENTAL

education, counseling

Other: lifestyle modified project

control

NO INTERVENTION

waiting list control

Interventions

lifestyle modified projectOTHER

education, counseling

lifestyle modified project

Eligibility Criteria

Age40 Years - 64 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • diagnosis of CAD by coroangiography
  • LVEF \>30%

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wan Fang Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Chii Jeng

    Taipei Medical University College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taipei Medical University

Study Record Dates

First Submitted

May 31, 2010

First Posted

June 3, 2010

Study Start

February 1, 2010

Primary Completion

August 1, 2012

Study Completion

August 1, 2012

Last Updated

March 22, 2023

Record last verified: 2023-03

Locations

TW(1)