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临床试验/NCT00123617
NCT00123617已完成2 期

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

National Heart and Lung Institute1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2003年1月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
64
试验地点
1
主要终点
Anxiety

研究概览

简要总结

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.

详细描述

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 with related chronic pain (14).

Frequency and severity of chest pain has been shown to have a direct effect on quality of life in Syndrome X patients (15). Sand (16) found that over a 7-year follow-up, a higher percentage of Syndrome X patients had given up work, reduced their daily activities and reported worsening chest pain in comparison to patients with confirmed coronary disease. Persistent functional incapacity with concomitant high levels of chest pain in patients with normal or near normal coronary arteries was also found after an 11-year follow-up (9). Use of anti-anginals was higher, as was their self reported burden on the health service.

The Collins team recently performed the largest psychosocial investigation of postmenopausal women with Syndrome X ever undertaken (17). The Hearts and Minds Study, which involved 100 Syndrome X patients, 100 patients with CHD and 100 healthy volunteers found that Syndrome X patients suffered significantly higher levels of anxiety than CHD patients or healthy controls. A greater number of Syndrome X patients suffered clinical levels of anxiety and depression than CHD patients and healthy volunteers, along with suffering significantly higher levels of psychological suffering as measured by the Health Anxiety Questionnaire than healthy controls. We also found that Syndrome X patients with a small social network had higher levels of anxiety than their counterparts with a larger social support structure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
30 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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

研究组 & 干预措施

Monitoring

No Intervention

Normal daily living, no extra visits to study centre

Phase III cardiac rehabilitation

Experimental

Phase III group-based cardiac rehabilitation classes, weekly

干预措施: Phase III group-based cardiac rehabilitation (Procedure)

结局指标

主要结局

Anxiety

时间窗: Measured at baseline then every 8 weeks for 16 weeks

Symptom severity

时间窗: Measured at baseline then continuously for 16 weeks

Depression

时间窗: Measured at baseline then every 8 weeks for 16 weeks

Health anxiety

时间窗: Measured at baseline then every 8 weeks for 16 weeks

Cardiac anxiety

时间窗: Measured at baseline then every 8 weeks for 16 weeks

Quality of life

时间窗: Measured at baseline then every 8 weeks for 16 weeks

Symptom frequency

时间窗: Measured at baseline then continuously for 16 weeks

次要结局

  • Cardiovascular risk factors(Measured at baseline, 8 weeks and 16 weeks.)
  • Physical ability(Baseline and at 8 weeks)
  • Time to pain(Baseline and 8 weeks)

研究者

发起方
National Heart and Lung Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Peter Collins

Professor of Clinical Cardiology

National Heart and Lung Institute

研究点 (1)

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