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Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography

NCT02377310 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 197

Last updated 2015-08-13

No results posted yet for this study

Summary

Instantaneous wave-free ratio (iFR™) is a novel non-hyperaemic index of the functional significance of a coronary stenosis. Previous studies have shown variable levels of correlation with the established hyperaemic index FFR. In addition it has been proposed that iFR™ has superior diagnostic accuracy when compared to mean whole cardiac cycle Pd/Pa which can also be used to predict FFR.

We plan to undertake a prospective clinical study in consecutive patients already undergoing FFR assessment in the cardiac catheterisation laboratory to compare the ability of iFR™ and Pd/Pa (both measured using the proprietary Volcano system) to predict FFR. We will explore the level of misclassification of flow limiting disease that results from use of iFR™ and resting Pd/Pa employed using either binary cut-off algorithms or in a hybrid decision making protocol. We plan to analyse 260 vessels over a 18 month period. Hyperaemia will be induced by intravenous adenosine (140 ug/kg/min) administered wherever possible via an antecubital vein. Intra-coronary nitrates will also be given in line with the standard care procedure for FFR measurement. Final clinical decisions following coronary physiology will be based on steady state FFR.

Conditions

Sponsors & Collaborators

  • Golden Jubilee National Hospital

    lead OTHER_GOV

Principal Investigators

  • Keith G Oldroyd, M.D. · Golden Jubilee National Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

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 NCT02377310 on ClinicalTrials.gov