The cost-effectiveness of functional cardiac testing in the diagnosis and management of coronary heart disease.
| ISRCTN | ISRCTN47108462 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47108462 |
| Protocol serial number | HTA 99/26/04 |
| Sponsor | Department of Health (UK) |
| Funder | NIHR Health Technology Assessment Programme - HTA (UK) |
- Submission date
- 25/04/2003
- Registration date
- 25/04/2003
- Last edited
- 12/02/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Cardiology
Papworth and West Suffolk Hospitals
Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
| Phone | +44 (0)1480 830541 |
|---|---|
| david.stone@papworth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Parallel group randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The aim of this study is to decide whether assessment of myocardial perfusion (by TcMIBI or perfusion MRI or stress echocardiography) in comparison to routine investigation (exercise testing and angiography) can improve the identification of patients who will benefit from revascularisation. The cost effectiveness of each regime will be analysed with respect to more precise targeting of appropriate patients and will include analysis of any implications of change in practice. This study is comparing the clinical and cost effectiveness of cardiac perfusion tests (stress echocardiography, stress MRI, stress MIBI) with the current gold standard test (angiography) for identifying those patients who will benefit from revascularisation (angioplasty or coronary bypass surgery). Patients with unstable angina are randomised to one of the four investigations and assessed at defined time points after treatment. The hypothesis behind this trial is that techniques which measure blood flow to the heart may be more effective than angiography at identifying those patients who are likely to benefit from revascularisation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cardiovascular diseases: Heart disease |
| Intervention | Group 1 (control) will have angiography Group 2 Tc-methoxyisobutylisonitrile (TcMIBI) Group 3 Magnetic Resonance Imaging (MRI) Group 4 will have stress echo. The referring cardiologist will have the option of proceeding to angiography but will be urged to do so only when the stress imaging test is 'positive' for reversible ischaemia. In order to assess clinical confidence in the additional investigations, the cardiologist will record their expected diagnosis and treatment strategy at baseline assessment. Patients will then proceed to appropriate treatment: Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Graft (CABG) or medical therapy. |
| Intervention type | Other |
| Primary outcome measure(s) |
The primary outcome measure is exercise capacity: treadmill time according to modified Bruce protocol measured at baseline, at 6 months following treatment with CABG, PTCA or medical therapy and at 18 months following entry to the trial. |
| Key secondary outcome measure(s) |
Secondary measures include the Canadian Cardiovascular Society classification of angina; health related quality of life assessments: the generic SF36, disease specific Seattle Angina Questionnaire and utility EQ-5D; cardiologist's assessment of IHD risk (compared with formal risk assessment) and treatment intentions expressed prior to the diagnostic test; patients' preferences; revascularisation rate; hospital admissions for unstable angina, incidence of MI and deaths after treatment. These outcome measures will be used to evaluate the contribution of functional data to successful revascularisation. Annuitized capital costs will be calculated for each of the imaging procedures. These will be combined with running, treatment, community and patient costs in an incremental cost-effectiveness analysis. |
| Completion date | 30/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 898 |
| Key inclusion criteria | Patients with chronic stable angina and a positive stress exercise test who are referred to designated Papworth cardiologists for angiography will be randomised to one of 4 groups. |
| Key exclusion criteria | Patients with recent (<3 months) MI, previous or urgent need for revascularisation, those known to have adverse reactions to pharmacological stress, incapable of performing ETT, pacemaker or other contraindication to MRI, not available by telephone. |
| Date of first enrolment | 01/07/2001 |
| Date of final enrolment | 30/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CB23 3RE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/12/2007 | Yes | No | |
| Results article | results | 07/02/2014 | Yes | No |
