The purpose of this study is to determine the diagnostic performances of iodine contrast medium and resting conditions to predict fractional flow reserve (FFR). Reference FFR will be measured using standard adenosine. We hypothesize that contrast FFR will offer superior diagnostic agreement compared to resting conditions.
We are conducting a diagnostic accuracy study. The reference standard is adenosine-derived FFR. The diagnostic tests undergoing evaluation are resting conditions and hyperemia induced by intracoronary injection of contrast medium. While all these tests give a continuous result, we will apply binary cutoffs for comparison to FFR≤0.8 as the reference standard. Subjects will be selected prospectively from consecutive patients undergoing FFR assessment for standard clinical indications. The paired comparative design means that each patient will undergo resting (baseline), post-contrast, and adenosine-derived measurements. To enhance test integrity, all pressure recordings will be analyzed in a central physiology core laboratory blinded to clinical data and recruiting site.
Study Type
OBSERVATIONAL
Enrollment
763
Intracoronary or intravenous adenosine to induce hyperemia for reference FFR
Intracoronary injection of contrast medium to induce hyperemia for "contrast FFR"
Baseline measurement of aortic and coronary pressures
Stanford University, Palo Alto VA
Palo Alto, California, United States
Integris Health
Oklahoma City, Oklahoma, United States
Cardiovascular Center (OLV-Ziekenhuis)
Aalst, Belgium
Agreement with binary FFR≤0.80
To quantify any improvement in binary agreement from resting conditions to contrast medium injection, using adenosine-derived FFR≤0.8 as the reference standard.
Time frame: Baseline
Binary diagnostic performance
To describe the diagnostic performance of resting conditions and contrast medium injection using sensitivity and specificity, positive and negative predictive value, and area under the receiver operating characteristic (ROC) curve, compared to adenosine-derived FFR≤0.8 as the reference standard.
Time frame: Baseline
Continuous relationship with FFR
To determine the relationship between adenosine-derived FFR and either resting conditions or contrast medium injection using scatter plots (correlation coefficient) and Bland-Altman analysis (bias and limits of agreement).
Time frame: Baseline
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Hôpital Louis Pradel
Lyon, France
University of Naples Federico II
Naples, Italy
Catharina Hospital
Eindhoven, North Brabant, Netherlands
Hospital Fernando Fonseca
Lisbon, Portugal
Seoul National University College of Medicine
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Södersjukhuset
Stockholm, Sweden
...and 1 more locations