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
Secondary identifying numbers	HTA 99/26/04

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Stone
Scientific

Department of Cardiology
Papworth and West Suffolk Hospitals
Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Phone	+44 (0)1480 830541
Email	david.stone@papworth.nhs.uk

Study information

Study design	Parallel group randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
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	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.
Secondary outcome measures	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.
Overall study start date	01/07/2001
Completion date	30/06/2006

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	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

England
United Kingdom

Study participating centre

Department of Cardiology

Cambridge
CB23 3RE
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone	+44 (0)1132 545 843
Email	Sheila.Greener@doh.gsi.gov.uk
Website	http://www.dh.gov.uk/en/index.htm
"ROR"	https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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