Condition category
Circulatory System
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
12/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/en/index.htm

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

  1. 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.

  2. 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.

Additional files

Editorial Notes