Clinical Trial: The Impact of Cardiac Rehabilitation Participation on Cardiac Syndrome X

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Impact of Cardiac Rehabilitation on Angina Frequency, Psychological Morbidity and Quality of Life in Women With Syndrome X

Brief Summary: 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.

Detailed Summary:

Very few clinicians treating patients with Syndrome X could dispute that despite an excellent prognosis, the debilitating symptomology and ineffective treatment regimes typical in this condition give patients a miserable quality of life. First identified by Kemp (1), the triad of angina pectoris, a positive exercise test for myocardial ischemia and angiographically smooth coronary arteries continues to perplex clinician seeking a useful treatment regime.

The possible pathophysiology of chest pain associated with Syndrome X is poorly understood in these patients. Suggested mechanisms include abnormal myocardial flow reserve due to coronary microvascular dysfunction ('microvascular angina') (2) or a generalised disorder of vascular function (3),(4) early signs of abnormal left ventricular function (5), which in some patients may deteriorate over time,(6) and abnormal visceral pain perception (7). Some patients exhibit insulin resistance (8). However, there have been few adequate systematic explorations of the psychological and social aspects of Syndrome X.

Several studies have found increased levels of anxiety in patients with normal or near normal coronary arteries in the presence of accompanying chest pain (9). Ruggeri et al (10) found higher level of neuroticism and anxiety in small group of patients with Syndrome X in comparison with patients with confirmed coronary artery disease. Panic disorders, sometimes associated with chest pain, are also often presented with depression, hypochondriasis or other somatoform disorders (11). Studies investigating various non-therapeutic treatment regimes have repeatedly shown that relaxation and stress reduction lead to fewer incidence of chest pain in Syndrome X patients (12). However, the same is also true for patients with CAD (13) along with many other conditions and disorders wit
Sponsor: National Heart and Lung Institute

Current Primary Outcome:

  • Anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  • Depression [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  • Health anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  • Cardiac anxiety [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  • Quality of life [ Time Frame: Measured at baseline then every 8 weeks for 16 weeks ]
  • Symptom severity [ Time Frame: Measured at baseline then continuously for 16 weeks ]
  • Symptom frequency [ Time Frame: Measured at baseline then continuously for 16 weeks ]


Original Primary Outcome:

  • Anxiety
  • Depression
  • Health anxiety
  • Cardiac anxiety
  • Quality of life
  • Symptom severity
  • Symptom frequency


Current Secondary Outcome:

  • Cardiovascular risk factors [ Time Frame: Measured at baseline, 8 weeks and 16 weeks. ]
  • Physical ability [ Time Frame: Baseline and at 8 weeks ]
  • Time to pain [ Time Frame: Baseline and 8 weeks ]


Original Secondary Outcome:

  • Cardiovascular risk factors
  • Physical ability
  • Time to pain


Information By: National Heart and Lung Institute

Dates:
Date Received: July 21, 2005
Date Started: January 2003
Date Completion:
Last Updated: April 21, 2015
Last Verified: April 2015