NCT05459051

Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 58 (estimated)
• Sponsor: Imperial College London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Stable Angina

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Rest-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.
DIAGNOSTIC_TEST	Exercise-angina physiological assessment	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.

Timeline

• Start date: 2022-09-01
• Primary completion: 2025-04-08
• Completion: 2025-04-08
• First posted: 2022-07-14
• Last updated: 2024-03-06

Locations

6 sites across 1 country: United Kingdom