The Impact of Cardiac Rehabilitation Participation on Cardiac Syndrome X

This study has been completed.
Sponsor:
Information provided by:
National Heart and Lung Institute
ClinicalTrials.gov Identifier:
NCT00123617
First received: July 21, 2005
Last updated: July 29, 2005
Last verified: May 2005
  Purpose

The study is designed to test the hypothesis that participation in a standard phase III group based cardiac rehabilitation programme will improve psychological morbidity, quality of life and cardiovascular risk factors, along with chest pain severity and frequency in women with cardiac syndrome X.


Condition Intervention Phase
Microvascular Angina
Procedure: Phase III group based cardiac rehabilitation
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Cardiac Rehabilitation on Angina Frequency, Psychological Morbidity and Quality of Life in Women With Syndrome X

Resource links provided by NLM:


Further study details as provided by National Heart and Lung Institute:

Primary Outcome Measures:
  • Anxiety
  • Depression
  • Health anxiety
  • Cardiac anxiety
  • Quality of life
  • Symptom severity
  • Symptom frequency

Secondary Outcome Measures:
  • Cardiovascular risk factors
  • Physical ability
  • Time to pain

Estimated Enrollment: 64
Study Start Date: January 2003
Estimated Study Completion Date: March 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women
  • Aged 30 to 80 years
  • Postmenopausal > 1 year since last menstrual period
  • Angiographically normal coronary arteries
  • Positive treadmill exercise test for myocardial ischemia
  • Reported angina pectoris > 2 episodes per week
  • Diagnosis > 6 months
  • Willing to give written informed consent

Exclusion Criteria:

  • History of psychiatric illness
  • History of any other chronic illness
  • Participation in another research study within the previous 60 days
  • Suffer any physical condition for which exercise is a contra-indication.
  • Unwilling to give written informed consent
  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: NCT00123617

Locations
United Kingdom
National Heart and Lung Institute, Imperial College London
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
National Heart and Lung Institute
Investigators
Principal Investigator: Peter Collins, MD FRCP National Heart and Lung Institute, Imperial College London
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00123617     History of Changes
Other Study ID Numbers: 02-239
Study First Received: July 21, 2005
Last Updated: July 29, 2005
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by National Heart and Lung Institute:
Chest pain
Women
Syndrome X
Cardiac rehabilitation
Psychological morbidity
Cardiovascular risk factors

Additional relevant MeSH terms:
Angina Pectoris
Microvascular Angina
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 20, 2014