Coronary Artery Disease
Conditions
Keywords
Fractional Flow Reserve, Myocardial, Adenosine, Contrast Media
Brief summary
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.
Detailed description
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.
Interventions
DRUGAdenosine
Intracoronary or intravenous adenosine to induce hyperemia for reference FFR
DRUGContrast Media
Intracoronary injection of contrast medium to induce hyperemia for contrast FFR
Baseline measurement of aortic and coronary pressures
Sponsors
Abbott Medical Devices
The University of Texas Health Science Center, Houston
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older. * Undergoing FFR assessment for standard clinical indications. * Ability to understand and willingness to sign a written informed consent.
Exclusion criteria
* Prior coronary artery bypass grafting (CABG). * Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements. Operators may exclude subtotal or similar high-grade lesions, which in their judgment may be threatened by pressure wire placement. * Known severe left ventricular hypertrophy (septal wall thickness at echocardiography of \>13 mm). * Inability to receive adenosine (for example, severe reactive airway disease, marked hypotension, or advanced atrioventricular block without pacemaker). * Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation myocardial infarction (STEMI) in any arterial distribution (not specifically target lesion). * Culprit lesions (based on clinical judgment of the operator) for either STEMI or non-STEMI cannot be included. * Severe cardiomyopathy (ejection fraction \<30%). * Renal insufficiency such that an additional 12 to 20 mL of contrast would, in the opinion of the operator, pose unwarranted risk to the patient.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement with binary FFR≤0.80 | Baseline | To quantify any improvement in binary agreement from resting conditions to contrast medium injection, using adenosine-derived FFR≤0.8 as the reference standard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Binary diagnostic performance | Baseline | 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 | Baseline | 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). |
Countries
Belgium, France, Italy, Netherlands, Portugal, South Korea, Sweden, United Kingdom, United States
Outcome results
None listed