National Heart and Lung Institute, Imperial College London
London, SW3 6LY, United Kingdom
NCT Number: NCT00411359
The purpose of this study is to determine whether cardiac rehabilitation is a successful treatment for refractory angina, in relation to improvements in cardiovascular risk factors, physical ability, symptomology, quality of life and psychological morbidity.
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Notify Me30 year–80 year
All sexes
Interventional
Phase 3
London, SW3 6LY, United Kingdom
The majority of patients presenting with angina pectoris resulting from coronary artery disease (CHD) are successfully treated with interventions including coronary artery bypass grafting (CABG) and percutaneous transluminal coronary angioplasty (PTCA) and medical management. However, a growing number of patients experience persistent angina in spite of intervention and optimal medical treatment. Such patients are referred to as suffering from 'refractory angina'.
Currently, cardiac rehabilitation centres are reluctant to accept patients with ongoing angina or complicated cardiovascular history, in spite of the duration or stability of the symptoms. Indeed, angina and heart failure are often used to exclude patients from cardiac rehabilitation. However, in the recent updated American Heart Association (AHA) recommendations for exercise and training, cardiac rehabilitation and supervised exercise training is recommended for patients with ongoing angina, previous history of CABG, MI, PTCA and patients with existing cardiomyopathy in order to promote a reduction in myocardial ischaemia at rest and during sub-maximal exercise, while reducing the risk for the progression of CHD. Nevertheless, studies exploring the physiological and psychological impact of routinely available CR as a stand-alone intervention among refractory angina patients have not previously been undertaken. Until such studies are performed, CR practitioners will continue to refuse to accept refractory angina patients for participation in CR.
Research questions:
The study is conceived as a randomised intervention-control study of a standard, routinely available Phase III hospital-based CR program among patients with refractory angina. Patients will be randomly assigned to an eight-week CR programme based at Harefield Hospital or symptom diary monitoring control group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Phase III cardiac rehabilitation programme
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Health anxiety questionnaire (HAQ)
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Hospital Anxiety and Depression scale (HADS)
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Measured after 10 minutes sitting, using automated machine (eg. Omron machine)
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Heart rate measured using automated machine (eg. Omron blood pressure machine) or manually at the radial pulse
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Weight, height, waist circumference (tape measure), hip circumference (tape measure), body mass index calculated from height and weight using the following website: http://www.nhlbisupport.com/bmi/bmi-m.htm
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Measured in biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time frame: Baseline
Measured using the ENRICHED social support instrument (ESSI)
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Measured using the York angina beliefs scale.
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Progressive shuttle walk test
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Subjects completed a daily symptom monitoring diary
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
SF-36 quality of life scale
Time frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Measured in the biochemistry departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Measured in the haematology departments of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques.
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Measured in the haematology department of the Royal Brompton & Harefield NHS Foundation Trust using standard techniques
National Heart and Lung Institute
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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