Flow velocity measurements are more feasible proximal to a coronary stenosis than distal to a stenosis. The conservation of mass principle dictates that proximal flow velocity measurements can be used as a substitute for distal flow velocity…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To document the relationship between coronary flow reserve assessed proximal
and distal to a stenosis.
Secondary outcome
- To document the relationship between hyperaemic coronary flow assessed
proximal and distal to a stenosis.
- To document the relationship between baseline coronary flow assessed proximal
and distal to a stenosis.
Background summary
Patients with stable angina complaints and suspected coronary artery disease
are often treated with percutaneous intervention (PCI). However, not all
epicardial stenosis benefit from treatment with PCI and are often better
treated with medication alone. To stratify epicardial stenosis that need
treatment, physiological assessment is necessary. Coronary pressure and flow
indices are able to distinguish significant stenosis and physiological guided
therapy improves outcomes and prognosis.
However, flow measurements are technically difficult and measurements distal of
a stenosis are suspectable for noise and failure of measurements.
Hypothetically, flow measurements proximal to a stenosis are equal to distal
measurements in absence of major branches. This study aims to assess this
hypothesis.
Study objective
Flow velocity measurements are more feasible proximal to a coronary stenosis
than distal to a stenosis. The conservation of mass principle dictates that
proximal flow velocity measurements can be used as a substitute for distal flow
velocity measurements. We hypothesize that proximal measurement of coronary
flow reserve can be used as a substitute for distal measurement of coronary
flow reserve.
Study design
Multi-centre, double-blind, randomized, cross-over study.
Study burden and risks
Compared to local practice standards that recommend physiological-guided
revascularization, no additional risks are related to the present study. It is
in general considerate that the use of sensor-equipped guide wires is safe. The
appearance of vessel wall damaging occurs in approximately 1 of 1000
procedures, hence the adoption of sensor-equipped guide wires is considered as
local standard care.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
* Age > 18 years
* Presentation with chronic coronary syndrome (Canadian Cardiovascular Society
(CCS) Class I-III)
* At least one epicardial stenosis in a native coronary artery with a clinical
indication for physiological measurements to inform decision-making.
* Ability to understand and the willingness to sign a written informed consent.
Exclusion criteria
* Left main involvement requiring revascularization, ostial lesions, tandem
stenosis.
* Prior CABG to target vessel.
* Extremely tortuous or calcified coronary arteries precluding intracoronary
physiologic measurements.
* Visible collateral flow to the target vessel
* Recent (within 3 weeks prior to cardiac catheterization) ST-segment elevation
myocardial infarction (STEMI) in any arterial distribution (not specifically
target lesion).
* Renal failure (MDRD calculated eGFR of <30).
* Pregnancy.
* Severe valvular abnormalities that require surgery
* Severely impaired left ventricular (LV) function (ejection fraction < 30%)
* Known severe LV hypertrophy (> 13 mm septal wall thickness) Inability to sign
an informed consent, due to any mental condition that renders the subject
unable to understand the nature, scope, and possible consequences of the trial
or due to mental retardation or language barrier.
Design
Recruitment
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 |
|---|---|
| CCMO | NL75970.018.20 |