An interventional study of Routine Measurement of FFR in Chest Pain, Stable Angina and Acute Coronary Syndrome, sponsored by University Hospital Southampton NHS Foundation Trust. Status unknown at 17 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-12.
Sponsored by University Hospital Southampton NHS Foundation Trust · Not applicable, Interventional, and Diagnostic
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).
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.
5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.
This study's enrollment of 1,100 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →University Hospital Southampton NHS Foundation Trust is the lead sponsor of 147 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
o Outline Initial Inclusion Criteria (before entry to cath lab):
Patient scheduled for coronary angiography for the:
Urgent investigation of a recent but stabilised, non-ST elevation acute coronary syndrome event
o Outline Angiographic Inclusion Criterion (after angiography):
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 exclusion criteria:
Angiographic phase exclusion criteria:
Patient not suitable for the immediate performance of a pressure wire assessment of all major vessels for any reason, for example:
Routine angiography will be performed according to local best practice
Additional investigation with the measurement of FFR in all major vessels
Device: Routine 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
Also known as: Pressure wire assessment
Primary Economic Outcome Measure
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.
Time frame: One year
Primary Quality of Life Outcome Measure
Patient reported quality of life at one year using the EQ-5D health questionnaire.
Time frame: One year
Management strategy information
· Proportion of vessels deemed to demonstrate flow-limiting disease and targeted for revascularisation in the declared initial management strategy.
Time frame: Reported once: Single declaration at index procedure after randomisation
Management strategy information
· Proportion of patients scheduled for management with medical therapy, percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) in the declared initial management strategy.
Time frame: Reported once: Single declaration at index procedure after randomisation
Angina symptoms
• Angina symptoms as reported by the research team after the 12 month contact, described by Canadian Cardiovascular Society Grade.
Time frame: One year
Angina symptoms
• Angina symptoms as reported by the patient with private completion of a screening form at 12 months, described by Canadian Cardiovascular Society Grade.
Time frame: One year
All-cause mortality
Time frame: One year
Number of hospitalisation events
Time frame: One year
Total hospital days
Time frame: One year
Hospitalisation events
Hospitalisation events coded as cerebro-vascular accident (CVA).
Time frame: One year
Hospitalisation events
Hospitalisation events coded as myocardial infarction.
Time frame: One year
Hospitalisation events
Hospitalisation events coded as Coronary revascularisation. This analysis will involve a pre-specified subgroup analysis of: * Planned revascularisation - if declared as the index strategy. * All additional revascularisation events.
Time frame: One year
Plan to share: No
This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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University Hospital Southampton NHS Foundation Trust