A Randomised Controlled Trial to Compare Routine Pressure Wire Assessment With Conventional Angiography in the Management of Patients With Coronary Artery Disease.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chest Pain
- Sponsor
- University Hospital Southampton NHS Foundation Trust
- Enrollment
- 1100
- Locations
- 17
- Primary Endpoint
- Primary Economic Outcome Measure
- Last Updated
- 6 years ago
Overview
Brief Summary
A randomised controlled trial to compare two strategies for the investigation of coronary artery disease at the time of angiography. Patients will be randomised to conventional angiography or additional, routine pressure wire assessment - measuring fractional flow reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow percutaneous coronary intervention (PCI) (experimental arm).
Detailed Description
The study will recruit patients undergoing angiography for the investigation of stable angina or for the assessment of a recent, but stabilised, non-ST elevation acute coronary syndrome event. Eligible patients who provide written informed consent will be randomised to conventional angiography or additional, routine pressure wire assessment - measuring fractional flow reserve (FFR) - in all main vessels judged as being of sufficient vessel calibre to allow percutaneous coronary intervention (PCI) (experimental arm). The study pragmatic design allows investigators to conduct all diagnostic and therapeutic management in accordance with prevailing best practice patterns. Study outcome measures will examine resource utilisation, patient reported quality of life and clinical events at 1 year.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Primary Economic Outcome Measure
Time Frame: One year
Resource utilisation as determined by hospital care costs at one year; All hospital admissions will be tracked using national hospital episode statistics; the cost of each episode will be derived from a cost model using standard UK tariffs. This analysis will compare the mean (or median) of the total hospital costs recorded for each patient over the 12 month follow-up period.
Primary Quality of Life Outcome Measure
Time Frame: One year
Patient reported quality of life at one year using the EQ-5D health questionnaire.
Secondary Outcomes
- Total hospital days(One year)
- Management strategy information(Reported once: Single declaration at index procedure after randomisation)
- Angina symptoms(One year)
- All-cause mortality(One year)
- Number of hospitalisation events(One year)
- Hospitalisation events(One year)