ORBITA-FIRE is a randomised, double-blinded, placebo controlled experimental study that will identify the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) thresholds that correlate with symptoms of angina for 58 patients measured invasively under experimental conditions.
Study Type
OBSERVATIONAL
Enrollment
58
The degree of stenosis required to cause angina at rest will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
The degree of stenosis required to cause angina during exercise will be measured under double-blinded placebo controlled conditions using sequential intracoronary balloon inflations. This will then be correlated with various physiological indices, including FFR and NHPR.
Mid and South Essex NHS Foundation Trust
Basildon, United Kingdom
RECRUITINGRoyal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, United Kingdom
RECRUITINGImperial College NHS Trust
London, United Kingdom
The FFR and NHPR value at which the patient experiences angina in a rest state
Values 0.00-1.00 (Lower = More significant disease)
Time frame: Intra-procedural
The FFR and NHPR value at which the patient experiences angina in an exercise state
Values 0.00-1.00 (Lower = More significant disease)
Time frame: Intra-procedural
The FFR difference between the rest and exercise states
Values 0.00-1.00 (Lower = More significant disease)
Time frame: Intra-procedural
The NHPR difference between the rest and exercise states
Values 0.00-1.00 (Lower = More significant disease)
Time frame: Intra-procedural
Angina severity score at the angina threshold
The patient scores the severity of the angina experienced during the procedure between 0-10 (Higher = More severe)
Time frame: Intra-procedural
Angina similarity score at the angina threshold
The patient scores the similarity of the angina experienced during the procedure against the angina experienced before the procedure between 0-10 (Higher = Most similar)
Time frame: Intra-procedural
Angina symptom type at the angina threshold
The patient will list all symptoms experienced at the angina threshold
Time frame: Intra-procedural
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Royal Free Hospital NHS Foundation Trust
London, United Kingdom
RECRUITINGSt George's University Hospitals NHS Foundation Trust
London, United Kingdom
RECRUITINGPortsmouth Hospitals NHS Trust
Portsmouth, United Kingdom
RECRUITING