cardiac disease Coronary artery disease
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Stable angina (CCS class I to 3, or Braunwald class I) 2. Scheduled for PCI or intracoronary evaluation of functional lesion severity (diagnostic catheterization) of at least one coronary lesion in a native coronary vessel of 40 * 80% diameter stenosis on visual estim
Exclusion criteria
Exclusion criteria: 1. Younger than 18 or older than 80 years of age 2. Multiple coronary lesions in the same coronary artery 3. Recent myocardial infarction or revascularization (less than 6 weeks prior to procedure) 4. Previous revascularization of the vessel of interest 5. Severe left ventricular dysfunction (LV ejection fraction less than 30%) 6. Severe renal insufficiency (eGRF according to sMDRD less than 30 mL/min/m2) 7. 50% or more diameter stenosis in left main coronary artery 8. Severe valvular abnormalities 9. Women of childbearing age without a negative pregnancy test or active birthcontrol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the sensitivity, specificity, and diagnostic accuracy of stenosis resistance index (SR) and instantaneous wave free ratio (iFR) during baseline conditions, as well as SR, and the pressure-drop at a fixed velocity (dPv) during contrast-medium induced sub-maximal hyperemia for myocardial ischemia as assessed by intracoronary adenosine-derived (40µg) HSR. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To determine the reproducibility and dose-response relationship of SR and dPv during contrast medium-induced sub-maximal hyperemia. 2. To determine the best cut-off value for SR and iFR during baseline conditions, as well as SR and dPv during sub-maximal hyperemia for myocardial ischemia as assessed by intracoronary adenosine-derived (40µg) HSR. 3. To determine the diagnostic accuracy of FFR, CFVR, and SR during regadenoson-induced maximal hyperemia for myocardial ischemia compared to intracoronary adenosine-derived (40µg) HSR. 4. To study the interaction between hemodynamic and mechanical factors responsible for the morphology of the coronary flow velocity and pressure waveforms during maximal coronary vasodilation compared to resting conditions,,and during a Valsalva maneuver. 5. To compare the results derived from high and low-dose intracoronary adenosine to contrast-derived and baseline parameters. 6. To relate the effect of different vasodilators on microvascular resistance, as well as the relationship between the objectified microvascular resistance and the parameters of functional lesion severity. 7. To relate parameters of functional lesion severity to long-term clinical outcome | — |
Countries
Netherlands
Outcome results
None listed