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Finding the Invasive Haemodynamic Threshold for Symptom Relief in Stable Angina

NCT05459051 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2024-03-06

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Royal Free Hospital NHS Foundation Trust

    collaborator OTHER

  • Mid and South Essex NHS Foundation Trust

    collaborator OTHER

  • St George's University Hospitals NHS Foundation Trust

    collaborator OTHER

  • Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

    collaborator OTHER_GOV

  • Portsmouth Hospitals NHS Trust

    collaborator OTHER_GOV

  • Imperial College London

    lead OTHER

Principal Investigators

  • Rasha Al-Lamee, PhD MRCP · Imperial College London

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2025-04-08
Completion
2025-04-08

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05459051 on ClinicalTrials.gov