Coronary Artery Disease Clinical Trial
— VERIFY2Official title:
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
Verified date | August 2015 |
Source | Golden Jubilee National Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | United Kingdom: National Health Service |
Study type | Observational |
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.
Status | Completed |
Enrollment | 197 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: All patients =18 years of age, already undergoing pressure wire assessment and able to consent Exclusion Criteria: Inability to receive adenosine Extremely tortuous vessels Highly calcified lesions unsuitable for pressure wire assessment coronary artery occlusion acute MI within 3 days |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United Kingdom | Golden Jubilee National Hospital | Glasgow | Dunbartonshire |
Lead Sponsor | Collaborator |
---|---|
Golden Jubilee National Hospital |
United Kingdom,
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. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | To determine the diagnostic accuracy of hybrid iFR™/FFR versus hybrid resting Pd/Pa/FFR in reference to FFR | Adenosine zone for iFR is 0.86-0.93, Adenosine zone for resting Pd/Pa is 0.87-0.94. | 30 days | Yes |
Secondary | To compare steady state FFR to minimum FFR | FFR recorded by the operator as the minimum value will be compared with the steady state value and the impact on vessel classification will be assessed | 30 days | Yes |
Secondary | To investigate the influence of hyperemia on iFR™. | iFR™ will be reassessed after administration of adenosine to evaluate whether this increases agreement with FFR. | 30 days | Yes |
Secondary | To assess the rate of revascularization per (1) artery and (2) per patient, associated with iFR™-guided management vs. FFR-guided management. | An analysis of the total number of vessels and patients that would potentially undergo revascularisation will be used to compare iFR™ versus FFR guided managment. | 30 days | Yes |
Secondary | To assess serious adverse events in patients receiving intravenous adenosine | Patients will be monitored during coronary physiology studies to assess the safety of intravenous adenosine infusion with assessment of side effects leading to early termination of the infusion. | 30 days | Yes |
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