Contact information
Type
Scientific
Primary contact
Dr David Stone
ORCID ID
Contact details
Department of Cardiology
Papworth and West Suffolk Hospitals
Papworth Hospital
Papworth Everard
Cambridge
CB23 3RE
United Kingdom
+44 (0)1480 830541
david.stone@papworth.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 99/26/04
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Parallel group randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/07/2001
Overall trial end date
30/06/2006
Reason abandoned
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
898
Participant 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.
Recruitment start date
01/07/2001
Recruitment end date
30/06/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Cardiology
Cambridge
CB23 3RE
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/18021576
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24508847
Publication citations
-
Results
Sharples L, Hughes V, Crean A, Dyer M, Buxton M, Goldsmith K, Stone D, Cost-effectiveness of functional cardiac testing in the diagnosis and management of coronary artery disease: a randomised controlled trial. The CECaT trial., Health Technol Assess, 2007, 11, 49, iii-iv, ix-115.
-
Results
Thom H, West NE, Hughes V, Dyer M, Buxton M, Sharples LD, Jackson CH, Crean AM, , Cost-effectiveness of initial stress cardiovascular MR, stress SPECT or stress echocardiography as a gate-keeper test, compared with upfront invasive coronary angiography in the investigation and management of patients with stable chest pain: mid-term outcomes from the CECaT randomised controlled trial., BMJ Open, 2014, 4, 2, e003419, doi: 10.1136/bmjopen-2013-003419.