The objective of this study is to increase our understanding of the relationship between various parameters of functional lesion severity, to optimize adenosine-free evaluation of functional lesion severity.
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
Contemporary evaluation of functional lesion severity by means of pressure- or
flow-velocity equipped guide wires per definition requires a maximal
vasodilated state. The use of potent vasodilators may however be cumbersome in
daily clinical practice, and there is a large debate on their optimal dose and
route of administration. Vasodilator-free evaluation of functional lesion
severity is expected to improve feasibility, as well as adoption of these
measurements in daily clinical practice.
Study objective
The objective of this study is to increase our understanding of the
relationship between various parameters of functional lesion severity, to
optimize adenosine-free evaluation of functional lesion severity.
Study design
Observational study with invasive measurements
Study burden and risks
The burden consists of 15 to 20 minutes enlenghtening of the PCI procedure,
with a minimal increase in radiation dose and contrast agent exposure. The
patient is furthermore contacted 6 times by telephone for follow-up. The risks
of participation with this study are considered negligible.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
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
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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-004759-35-NL |
| CCMO | NL42381.018.12 |