An observational study in Stable Angina, sponsored by Imperial College London. Recruiting at 6 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Imperial College London · Observational
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.
343 studies on the registry are indexed under Angina, Stable; 56 are open to participants now.
This study's planned enrollment of 58 is below the median of 508 across 103 observational studies indexed under Angina, Stable.
Browse Angina, Stable studies →Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patient with stable angina
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Anatomical evidence of significant single-vessel coronary stenosis defined by either:
Physiological evidence of ischaemia with a positive test on at least one of the following:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Symptomatic * Anatomically severe single-vessel coronary artery disease * Physiological evidence of myocardial ischaemia
Diagnostic Test: Rest-angina physiological assessment · Diagnostic Test: Exercise-angina physiological assessment
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.
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
Plan to share: No
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