Pd/Pa vs iFR™ in an Unselected Population Referred for Invasive Angiography
VERIFY2
A Comparative Study of Resting Coronary Pressure Gradient, Instantaneous Wave-free Ratio and Fractional Flow Reserve in an Unselected Population Referred for Invasive Angiography: The VERIFY 2 Study
1 other identifier
observational
197
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 26, 2015
CompletedFirst Posted
Study publicly available on registry
March 3, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2015
CompletedAugust 13, 2015
August 1, 2015
1.6 years
February 26, 2015
August 11, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the diagnostic accuracy of instantaneous wave-free ratio (binary cut-off value 0.90) versus resting Pd/Pa (binary cut-off value 0.92) in reference to FFR.
Resting Pd/Pa will be compared to iFR™ in reference to FFR.
30 days
Secondary Outcomes (5)
To determine the diagnostic accuracy of hybrid iFR™/FFR versus hybrid resting Pd/Pa/FFR in reference to FFR
30 days
To compare steady state FFR to minimum FFR
30 days
To investigate the influence of hyperemia on iFR™.
30 days
To assess the rate of revascularization per (1) artery and (2) per patient, associated with iFR™-guided management vs. FFR-guided management.
30 days
To assess serious adverse events in patients receiving intravenous adenosine
30 days
Study Arms (1)
All patients
All patients will undergo coronary physiological study with measurement of resting Pd/Pa, iFR™, hyperaemic iFR and FFR.
Eligibility Criteria
All consecutive patients undergoing FFR assessment for standard clinical indications.
You may qualify if:
- All patients ≥18 years of age, already undergoing pressure wire assessment and able to consent
You may not qualify if:
- Inability to receive adenosine
- Extremely tortuous vessels
- Highly calcified lesions unsuitable for pressure wire assessment
- coronary artery occlusion
- acute MI within 3 days
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Golden Jubilee National Hospital
Glasgow, Dunbartonshire, G81 4DY, United Kingdom
Related Publications (3)
Bossuyt PM, Reitsma JB, Bruns DE, Gatsonis CA, Glasziou PP, Irwig LM, Lijmer JG, Moher D, Rennie D, de Vet HC; Standards for Reporting of Diagnostic Accuracy. Towards complete and accurate reporting of studies of diagnostic accuracy: the STARD initiative. Clin Radiol. 2003 Aug;58(8):575-80. doi: 10.1016/s0009-9260(03)00258-7.
PMID: 12887949BACKGROUNDVan't Veer M, Pijls NHJ, Hennigan B, Watkins S, Ali ZA, De Bruyne B, Zimmermann FM, van Nunen LX, Barbato E, Berry C, Oldroyd KG. Comparison of Different Diastolic Resting Indexes to iFR: Are They All Equal? J Am Coll Cardiol. 2017 Dec 26;70(25):3088-3096. doi: 10.1016/j.jacc.2017.10.066.
PMID: 29268922DERIVEDHennigan B, Oldroyd KG, Berry C, Johnson N, McClure J, McCartney P, McEntegart MB, Eteiba H, Petrie MC, Rocchiccioli P, Good R, Lindsay MM, Hood S, Watkins S. Discordance Between Resting and Hyperemic Indices of Coronary Stenosis Severity: The VERIFY 2 Study (A Comparative Study of Resting Coronary Pressure Gradient, Instantaneous Wave-Free Ratio and Fractional Flow Reserve in an Unselected Population Referred for Invasive Angiography). Circ Cardiovasc Interv. 2016 Nov;9(11):e004016. doi: 10.1161/CIRCINTERVENTIONS.116.004016.
PMID: 27834663DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Keith G Oldroyd, M.D.
Golden Jubilee National Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2015
First Posted
March 3, 2015
Study Start
September 1, 2013
Primary Completion
April 1, 2015
Study Completion
April 1, 2015
Last Updated
August 13, 2015
Record last verified: 2015-08