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The cost-effectiveness of functional cardiac testing in the diagnosis and management of coronary heart disease.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN47108462
Enrollment
898
Registered
2003-04-25
Start date
2001-07-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular diseases: Heart disease Circulatory System Heart disease

Interventions

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 o

Sponsors

Department of Health (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026