The purpose of this study is to advance our understanding of the behaviour of the coronary microcirculation in the setting of NSTE-ACS, to provide insights into the relationship between Doppler flow velocity and thermodilution-derived coronary…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To document the magnitude of microvascular resistance in patients with NSTE-ACS
versus patients with stable coronary artery disease, as obtained from Doppler
flow velocity-derived and thermodilution mean transit time-derived surrogates
of coronary flow.
Secondary outcome
To document the relative magnitude of absolute coronary flow and coronary flow
reserve in patients with NSTE-ACS versus patients with stable coronary artery
disease, as obtained from Doppler flow velocity-derived and thermodilution mean
transit time-derived surrogates of coronary flow.
To determine the relationship between Doppler flow velocity-derived and
thermodilution-derived mean transit time-derived surrogates of coronary flow,
coronary flow reserve, and the derived indices of microvascular resistance.
To determine the effect of intravenous versus intracoronary administration of
adenosine on maximal coronary flow and coronary flow reserve.
To determine the relevance of correction of coronary flow and coronary flow
reserve for the loss of perfusion pressure after intravenous administration of
adenosine.
To determine the potential of advanced analysis of the coronary angiogram for
the assessment of coronary flow and resistance parameters through fluid dynamic
modelling.
Background summary
Although the use of coronary physiology techniques in contemporary clinical
practice is dominated by the use of coronary pressure to guide epicardial
revascularization, a comprehensive assessment of coronary physiology only can
be achieved by measuring both coronary pressure and flow simultaneously. The
resistance of a vascular compartment is defined as the ratio of the pressure
drop over it to the flow through it, the measurement of both coronary pressure
and flow simultaneously during cardiac catheterization allows the selective
interrogation of the resistance to coronary flow induced by the epicardial and
microvascular compartments of the interrogated coronary vascular bed. Evidence
is accumulating that the resistance induced by the coronary microcirculation is
an important contributor to the occurrence of myocardial ischemia, importantly
influences the diagnosis of the functional severity of epicardial coronary
stenoses by coronary pressure measurements, and even poses an independent risk
factor for adverse clinical outcome when it is abnormal, both in stable
coronary artery disease and ST-segment elevation myocardial infarction patients
(STEMI).
These findings indicate an important role of coronary microvascular function in
the spectrum of coronary artery disease. Although the spectrum of
acute coronary syndromes is considered a sliding scale in terms of ischemic
burden to the myocardium, increasing in severity from unstable angina pectoris
to STEMI, the clinical outcome of NSTE-ACS is counter intuitively equivalent to
that of STEMI. Considering the well-documented influence of microvascular
function on clinical outcome, both in stable coronary artery disease and
STEMI-populations, it may be considered that the functional consequences of the
ischemic event in the setting of NSTE-ACS may precipitate adverse outcome in a
similar manner as in STEMI. Unfortunately, clinical coronary physiology data in
the setting of NSTE-ACS is minimal. Moreover, the available data has been
obtained with different equipment and methodology than that used in the pivotal
stable coronary artery disease and STEMI studies.
Study objective
The purpose of this study is to advance our understanding of the behaviour of
the coronary microcirculation in the setting of NSTE-ACS, to provide insights
into the relationship between Doppler flow velocity and thermodilution-derived
coronary physiological parameters and their use in advanced physiological
indices of coronary resistance, and to identify the effect of systemic versus
local administration of vasodilators on coronary flow and flow reserve and
potential for its correction. Hence, this study aims to document 1) the
magnitude of microvascular resistance, maximal coronary flow and coronary flow
reserve in the setting of NSTE-ACS relative to a stable coronary artery disease
population 2) the relationship between Doppler flow velocity-derived and
thermodilution mean transit time-derived coronary flow, and the derived indices
of stenosis and microvascular resistance, and 3) the effect of intravenous
versus intracoronary administration of adenosine on maximal coronary flow and
coronary flow reserve, and the pertinence of correction for loss of perfusion
pressure.
Study design
This study is designed as a single-center, cross-sectional randomized studie
with invasive measurements.
Study burden and risks
The use of sensor-tipped guide wires in diseased coronary arteries is
considered safe. The appearance of damaging of the vessel wall occurs in
approximately 1 of 1000 procedures. The appearance of vessel wall damaging in
healthy vessels is even considered lower. The measurements will be conducted
according study protocol and are not standard cardiac care. However, since the
measurements are considered safe with a risk of vessel wall damaging of less
then 1 in a 1000, the extra risks coherent to the study protocol are
negligible. Therewithall, the measurements offer additional information
regarding the spectrum of coronary artery disease which are of therapeutical
and prognostic value. It has already been proven that microvascular dysfunction
can be considered as an important contributor to adverse clinical outcome in
patients with stable coronary artery disease or in the setting of STEMI. The
additional intracoronary measurements allow an early diagnostics of a
compromised microcirculation on which the treating doctor can anticipate in an
early setting. The advantages of the additional measurements outweight the
limited risk profile of intracoronary measurements.
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 III, or Braunwald class I) or NSTE-ACS (Chest pain within the preceding 5 days and an index event >24 hours from time of angiography but within the previous 7 days).;2. Scheduled for percutaneous coronary intervention or intracoronary evaluation of functional stenosis severity (diagnostic catheterization).;3. The presence of at least one normal or minimally diseased reference coronary artery (<30% diameter stenosis on visual assessment) with a vessel diameter of more than 2.5 mm.
Exclusion criteria
1. Younger than 19 or older than 80 years of age.;2. Recent ST-segment elevation myocardial infarction (<6 weeks prior to enrollment).;3. Inability to receive intravenous adenosine (for example, severe reactive airway disease, marked hypotension, or high-grade AV block without pacemaker).;4. Known renal insufficiency (eGRF according to MDRD <30 mL/min/m2).;5. Known severe valvular abnormalities.;6. Known severe left ventricular dysfunction (LV ejection fraction <30%) or known myocardial hypertrophy (septal wall thickness at echocardiography of >13 mm).;7. Extremely tortuous or calcified coronary arteries precluding intracoronary physiologic measurements.;8. Women of child bearing age not on active birth control;9. 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 | NL58034.018.16 |