Angina PectorisPhase 3NCT00411359
Cardiac Rehabilitation for the Treatment of Refractory Angina
A Phase 3 study testing Cardiac rehabilitation in people with Angina Pectoris and Coronary Disease, run by National Heart and Lung Institute at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Angina Pectoris, Coronary Disease
- What is being tested?
- Cardiac rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2006to Apr 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinically diagnosed with refractory angina > 6 months
- Two or more episodes of angina per week
- Males and females aged 30 - 80
- Previous history of single or multiple myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or any combination of the above
- Prescribed optimal medical therapy
- AHA exercise and training guidelines classification B and C
- Willing to give written informed consent
Who cannot join
- History of any other chronic illness
- AHA exercise and training guidelines classification class D
- Suffer any physical condition for which exercise is a contra-indication
- Participation in two or more periods of planned moderate intensity exercise per week during the past 6 months
- Participation in another research study within the previous 60 days
- History of psychiatric illness
- Unwilling to give written informed consent
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
National Heart and Lung Institute, Imperial College London
London, SW3 6LY
About this study
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.
Read the detailed description
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:
- Is an eight-week cardiac rehabilitation exercise programme an appropriate treatment option for patients with refractory angina?
- Does an eight-week cardiac rehabilitation exercise programme improve the physical functioning and cardiovascular health of patients with refractory angina?
- Is symptom severity and frequency reduced following an eight-week cardiac rehabilitation exercise programme in patients with refractory angina?
- Does an eight-week cardiac rehabilitation exercise programme have any impact on anxiety, depression, cardiac anxiety and quality of life in patients with refractory angina?
- Are any physiological or psychological effects acquired by patients with refractory angina participating in a cardiac rehabilitation exercise programme maintained at an eight-week follow-up?
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.
- Conditions
- Angina Pectoris, Coronary Disease
- Being tested
- Cardiac rehabilitation
- Keywords
- Refractory angina, Cardiac rehabilitation, Symptomology, Physical ability, Exercise, Psychology, Quality of life, Risk factors
- Medical subject headings
- Angina Pectoris, Coronary Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac rehabilitationBehavioural
Phase III cardiac rehabilitation programme
| Study group | Role | What they receive |
|---|---|---|
| Cardiac rehabilitation | Experimental | 8-week cardiac rehabilitation programme Receives: Behavioral: Cardiac rehabilitation |
| Monitoring | No intervention | Carry on life as normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health anxiety
Health anxiety questionnaire (HAQ)
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Generalised anxiety and depression
Hospital Anxiety and Depression scale (HADS)
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Secondary outcomes (15)
Systolic and diastolic blood pressure
Measured after 10 minutes sitting, using automated machine (eg. Omron machine)
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Heart rate
Heart rate measured using automated machine (eg. Omron blood pressure machine) or manually at the radial pulse
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Anthropomometry
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
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Fasting lipids
total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides. Measured in biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Social support
Measured using the ENRICHED social support instrument (ESSI)
Measured: Baseline
Angina related health beliefs
Measured using the York angina beliefs scale.
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Physical activity and exercise capacity
Progressive shuttle walk test
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Angina frequency and severity
Subjects completed a daily symptom monitoring diary
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Quality of life
SF-36 quality of life scale
Measured: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Plasma glucose
Measured in the biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Measured: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Urea & electrolytes
Measured in the biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques
Measured: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Liver function tests
Measured in the biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Measured: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Thyroid function tests
Measured in the biochemistry departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Measured: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Hb
Measured in the haematology departments of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques.
Measured: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
HbA1C (if diabetic)
Measured in the haematology department of the Royal Brompton \& Harefield NHS Foundation Trust using standard techniques
Measured: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionDec 2009
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Angina PectorisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Heart and Lung Institute
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, Royal Brompton & Harefield NHS Foundation Trust
- Responsible party
- Principal investigator, Prof. Peter Collins, National Heart and Lung Institute
- Investigators
- Peter Collins, MA, MD, FRCP, Principal investigator, National Heart and Lung Institute, Imperial College LondonKim Fox, MD, FRCP, Principal investigator, Royal Brompton & Harefield NHS Foundation TrustMahmud Barbir, FRCP, Principal investigator, Royal Brompton & Harefield NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411359
- Sponsor's protocol ID
- 06/Q0404/77
- Other IDs
- PG/06/087/21239
- Status last verified
- Apr 2015
- First submitted
- 12 Dec 2006
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002 Mar;23(5):355-70. doi: 10.1053/euhj.2001.2706. No abstract available.
PubMed 11846493DeJongste MJ, Tio RA, Foreman RD. Chronic therapeutically refractory angina pectoris. Heart. 2004 Feb;90(2):225-30. doi: 10.1136/hrt.2003.025031. No abstract available.
PubMed 14729809Gowda RM, Khan IA, Punukollu G, Vasavada BC, Nair CK. Treatment of refractory angina pectoris. Int J Cardiol. 2005 May 11;101(1):1-7. doi: 10.1016/j.ijcard.2004.03.066.
PubMed 15860376Chester M, Hammond C, Leach A. Long-term benefits of stellate ganglion block in severe chronic refractory angina. Pain. 2000 Jul;87(1):103-105. doi: 10.1016/S0304-3959(00)00270-0.
PubMed 10863051Stewart S. Refractory to medical treatment but not to nursing care: can we do more for patients with chronic angina pectoris? Eur J Cardiovasc Nurs. 2003 Sep;2(3):169-70. doi: 10.1016/S1474-5151(03)00067-7. No abstract available.
PubMed 14622623Moore RK, Groves D, Bateson S, Barlow P, Hammond C, Leach AA, Chester MR. Health related quality of life of patients with refractory angina before and one year after enrolment onto a refractory angina program. Eur J Pain. 2005 Jun;9(3):305-10. doi: 10.1016/j.ejpain.2004.07.013.
PubMed 15862480Lear SA, Ignaszewski A. Cardiac rehabilitation: a comprehensive review. Curr Control Trials Cardiovasc Med. 2001;2(5):221-232. doi: 10.1186/cvm-2-5-221.
PubMed 11806801Hevey D, Brown A, Cahill A, Newton H, Kierns M, Horgan JH. Four-week multidisciplinary cardiac rehabilitation produces similar improvements in exercise capacity and quality of life to a 10-week program. J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):17-21. doi: 10.1097/00008483-200301000-00004.
PubMed 12576907Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation I: review of psychosocial factors. Gen Hosp Psychiatry. 2002 May-Jun;24(3):121-6. doi: 10.1016/s0163-8343(02)00178-0.
PubMed 12062135Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation II: referral and participation. Gen Hosp Psychiatry. 2002 May-Jun;24(3):127-34. doi: 10.1016/s0163-8343(02)00179-2.
PubMed 12062136Johnston M, Foulkes J, Johnston DW, Pollard B, Gudmundsdottir H. Impact on patients and partners of inpatient and extended cardiac counseling and rehabilitation: a controlled trial. Psychosom Med. 1999 Mar-Apr;61(2):225-33. doi: 10.1097/00006842-199903000-00015.
PubMed 10204976Yoshida T, Kohzuki M, Yoshida K, Hiwatari M, Kamimoto M, Yamamoto C, Meguro S, Endo N, Kato A, Kanazawa M, Sato T. Physical and psychological improvements after phase II cardiac rehabilitation in patients with myocardial infarction. Nurs Health Sci. 1999 Sep;1(3):163-70. doi: 10.1046/j.1442-2018.1999.00021.x.
PubMed 10894639Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Pina IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the American Heart Association. Circulation. 2001 Oct 2;104(14):1694-740. doi: 10.1161/hc3901.095960. No abstract available.
PubMed 11581152Taylor RS, Brown A, Ebrahim S, Jolliffe J, Noorani H, Rees K, Skidmore B, Stone JA, Thompson DR, Oldridge N. Exercise-based rehabilitation for patients with coronary heart disease: systematic review and meta-analysis of randomized controlled trials. Am J Med. 2004 May 15;116(10):682-92. doi: 10.1016/j.amjmed.2004.01.009.
PubMed 15121495Asbury EA, Creed F, Collins P. Distinct psychosocial differences between women with coronary heart disease and cardiac syndrome X. Eur Heart J. 2004 Oct;25(19):1695-701. doi: 10.1016/j.ehj.2004.07.035.
PubMed 15451147
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Rehabilitation for the Treatment of Refractory Angina
- ClinicalTrials.gov ID
- NCT00411359
- Acronym / sponsor ID
- 06/Q0404/77
- Conditions
- Angina Pectoris, Coronary Disease
- Keywords
- Refractory angina, Cardiac rehabilitation, Symptomology, Physical ability, Exercise, Psychology, Quality of life, Risk factors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- National Heart and Lung InstituteUniversity, hospital or other
- Collaborators
- British Heart Foundation, Royal Brompton & Harefield NHS Foundation Trust
- Study start
- Dec 2006
- Primary completion
- Dec 2009 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 14 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Is an eight-week cardiac rehabilitation exercise programme an appropriate treatment option for patients with refractory angina?
- Does an eight-week cardiac rehabilitation exercise programme improve the physical functioning and cardiovascular health of patients with refractory angina?
- Is symptom severity and frequency reduced following an eight-week cardiac rehabilitation exercise programme in patients with refractory angina?
- Does an eight-week cardiac rehabilitation exercise programme have any impact on anxiety, depression, cardiac anxiety and quality of life in patients with refractory angina?
- Are any physiological or psychological effects acquired by patients with refractory angina participating in a cardiac rehabilitation exercise programme maintained at an eight-week follow-up?
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac rehabilitation | Experimental | Behavioral: Cardiac rehabilitation8-week cardiac rehabilitation programme |
| Monitoring | No intervention | –Carry on life as normal |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinically diagnosed with refractory angina > 6 months
- Two or more episodes of angina per week
- Males and females aged 30 - 80
- Previous history of single or multiple myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) or any combination of the above
- Prescribed optimal medical therapy
Key exclusion criteria (7 listed)
- History of any other chronic illness
- AHA exercise and training guidelines classification class D
- Suffer any physical condition for which exercise is a contra-indication
- Participation in two or more periods of planned moderate intensity exercise per week during the past 6 months
- Participation in another research study within the previous 60 days
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac rehabilitationPhase III cardiac rehabilitation programme | Behavioural | Cardiac rehabilitation |
Primary outcome
Health anxiety
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Health anxiety questionnaire (HAQ)
Generalised anxiety and depression
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Hospital Anxiety and Depression scale (HADS)
15 secondary outcomes
Systolic and diastolic blood pressure
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Heart rate
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Anthropomometry
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Fasting lipids
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Social support
Time frame: Baseline
Angina related health beliefs
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Physical activity and exercise capacity
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Angina frequency and severity
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Quality of life
Time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)
Plasma glucose
Time frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Urea & electrolytes
Time frame: Base, post intervention/monitoring, 8 weeks post intervention/monitoring
Liver function tests
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Thyroid function tests
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Hb
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
HbA1C (if diabetic)
Time frame: Baseline, post intervention/monitoring, 8 weeks post intervention/monitoring
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Background: PubMed 11846493Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002 Mar;23(5):355-70. doi: 10.1053/euhj.2001.2706. No abstract available.
- Background: PubMed 14729809DeJongste MJ, Tio RA, Foreman RD. Chronic therapeutically refractory angina pectoris. Heart. 2004 Feb;90(2):225-30. doi: 10.1136/hrt.2003.025031. No abstract available.
- Background: PubMed 15860376Gowda RM, Khan IA, Punukollu G, Vasavada BC, Nair CK. Treatment of refractory angina pectoris. Int J Cardiol. 2005 May 11;101(1):1-7. doi: 10.1016/j.ijcard.2004.03.066.
- Background: PubMed 10863051Chester M, Hammond C, Leach A. Long-term benefits of stellate ganglion block in severe chronic refractory angina. Pain. 2000 Jul;87(1):103-105. doi: 10.1016/S0304-3959(00)00270-0.
- Background: PubMed 14622623Stewart S. Refractory to medical treatment but not to nursing care: can we do more for patients with chronic angina pectoris? Eur J Cardiovasc Nurs. 2003 Sep;2(3):169-70. doi: 10.1016/S1474-5151(03)00067-7. No abstract available.
- Background: PubMed 15862480Moore RK, Groves D, Bateson S, Barlow P, Hammond C, Leach AA, Chester MR. Health related quality of life of patients with refractory angina before and one year after enrolment onto a refractory angina program. Eur J Pain. 2005 Jun;9(3):305-10. doi: 10.1016/j.ejpain.2004.07.013.
- Background: PubMed 11806801Lear SA, Ignaszewski A. Cardiac rehabilitation: a comprehensive review. Curr Control Trials Cardiovasc Med. 2001;2(5):221-232. doi: 10.1186/cvm-2-5-221.
- Background: PubMed 12576907Hevey D, Brown A, Cahill A, Newton H, Kierns M, Horgan JH. Four-week multidisciplinary cardiac rehabilitation produces similar improvements in exercise capacity and quality of life to a 10-week program. J Cardiopulm Rehabil. 2003 Jan-Feb;23(1):17-21. doi: 10.1097/00008483-200301000-00004.
- Background: PubMed 12062135Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation I: review of psychosocial factors. Gen Hosp Psychiatry. 2002 May-Jun;24(3):121-6. doi: 10.1016/s0163-8343(02)00178-0.
- Background: PubMed 12062136Grace SL, Abbey SE, Shnek ZM, Irvine J, Franche RL, Stewart DE. Cardiac rehabilitation II: referral and participation. Gen Hosp Psychiatry. 2002 May-Jun;24(3):127-34. doi: 10.1016/s0163-8343(02)00179-2.
- Background: PubMed 10204976Johnston M, Foulkes J, Johnston DW, Pollard B, Gudmundsdottir H. Impact on patients and partners of inpatient and extended cardiac counseling and rehabilitation: a controlled trial. Psychosom Med. 1999 Mar-Apr;61(2):225-33. doi: 10.1097/00006842-199903000-00015.
- Background: PubMed 10894639Yoshida T, Kohzuki M, Yoshida K, Hiwatari M, Kamimoto M, Yamamoto C, Meguro S, Endo N, Kato A, Kanazawa M, Sato T. Physical and psychological improvements after phase II cardiac rehabilitation in patients with myocardial infarction. Nurs Health Sci. 1999 Sep;1(3):163-70. doi: 10.1046/j.1442-2018.1999.00021.x.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Collins, MA, MD, FRCP principal investigator
National Heart and Lung Institute, Imperial College London
Kim Fox, MD, FRCP principal investigator
Royal Brompton & Harefield NHS Foundation Trust
Mahmud Barbir, FRCP principal investigator
Royal Brompton & Harefield NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cardiac rehabilitation in people with Angina Pectoris and Coronary Disease, run by National Heart and Lung Institute at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health anxiety (time frame: Base, week 8 (post intervention/monitoring), week 16 (8 weeks post intervention/monitoring)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00411359, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2015.