CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)
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.
Coronary Artery Disease
Drug: Contrast Media
Drug: Resting conditions
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||CONTRAST (Can cONTrast Injection Better Approximate FFR compAred to Pure reSTing Physiology?)|
- Agreement with binary FFR≤0.80 [ Time Frame: Baseline ] [ Designated as safety issue: No ]To quantify any improvement in binary agreement from resting conditions to contrast medium injection, using adenosine-derived FFR≤0.8 as the reference standard.
- Binary diagnostic performance [ Time Frame: Baseline ] [ Designated as safety issue: No ]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.
- Continuous relationship with FFR [ Time Frame: Baseline ] [ Designated as safety issue: No ]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).
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||August 2015|
|Estimated Primary Completion Date:||August 2015 (Final data collection date for primary outcome measure)|
Entire cohort undergoes paired testing
Intracoronary or intravenous adenosine to induce hyperemia for reference FFRDrug: Contrast Media
Intracoronary injection of contrast medium to induce hyperemia for "contrast FFR"Drug: Resting conditions
Baseline measurement of aortic and coronary pressures
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02184117
|United States, California|
|Stanford University, Palo Alto VA|
|Palo Alto, California, United States, 94304|
|United States, Oklahoma|
|Oklahoma City, Oklahoma, United States, 73112|
|Cardiovascular Center (OLV-Ziekenhuis)|
|Hôpital Louis Pradel|
|University of Naples Federico II|
|Naples, Italy, 80131|
|Korea, Republic of|
|Asan Medical Center|
|Seoul, Korea, Republic of, 138-736|
|Seoul National University College of Medicine|
|Seoul, Korea, Republic of, 110-744|
|Eindhoven, Noord-Brabant, Netherlands, 5623EJ|
|Hospital Fernando Fonseca|
|Golden Jubilee National Hospital|
|Clydebank, United Kingdom, G81 4HX|
|Principal Investigator:||Nils P Johnson, MD, MS||University of Texas Medical School at Houston|
|Study Director:||William F Fearon, MD||Stanford University|