Acute Coronary Syndrome, Chest Pain, Non ST Segment Elevation Acute Coronary Syndrome, Stable Angina
Conditions
Keywords
Fractional flow reserve (FFR), Pressure wire (PW), Coronary angiography
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.
Interventions
DEVICERoutine Measurement of FFR
FFR measurement will be performed in all major vessels with normal (TIMI 3) flow. Occluded vessels and vessels with TIMI flow \<3 will not be examined but will be 'awarded' an FFR value of 0.5
Sponsors
Liverpool Heart and Chest Hospital NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
· Inclusion criteria o Outline Initial Inclusion Criteria (before entry to cath lab): Patient scheduled for coronary angiography for the: * Elective investigation of known or suspected coronary artery disease OR * Urgent investigation of a recent but stabilised, non-ST elevation acute coronary syndrome event o Outline Angiographic Inclusion Criterion (after angiography): * Presence of significant coronary disease defined as: Any stenosis \>30% reduction in luminal diameter, by visual estimate, in at least one vessel (main or branch) of sufficient calibre to permit the potential performance of PCI - approximately 2.25 mm diameter. * Key
Exclusion criteria
* Screening phase
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Economic Outcome Measure | 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 | One year | Patient reported quality of life at one year using the EQ-5D health questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | One year | — |
| Number of hospitalisation events | One year | — |
| Management strategy information | Reported once: Single declaration at index procedure after randomisation | · Proportion of vessels deemed to demonstrate flow-limiting disease and targeted for revascularisation in the declared initial management strategy. |
| Hospitalisation events | One year | Hospitalisation events coded as cerebro-vascular accident (CVA). |
| Total hospital days | One year | — |
| Angina symptoms | One year | • Angina symptoms as reported by the research team after the 12 month contact, described by Canadian Cardiovascular Society Grade. |
Countries
United Kingdom
Outcome results
None listed