To assess the diagnostic value and feasibility of CFR measurement by TTDE as compared to invasive measurement (Gold standard).
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
coronary microvascular dysfunction (CMD)
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1) To appraise the agreement between non-invasive CFR measurements using
echocardiography (TTDE) and invasively measured CFR.
2) To evaluate the feasibility of a CFR measurement using TTDE.
3) To assess the intra-operator variability of TTDE
Secondary outcome
not applicable
Background summary
Over 60% of women and 30% of men undergoing coronary angiography for signs and
symptoms of ischemia have normal coronary arteries or non-obstructive coronary
artery disease (CAD) (<50% stenosis). Many of these patients suffer severe,
persistent symptoms despite anti-ischemic therapy. This leads to diminished
quality of life, substantial healthcare costs and, despite what was previously
thought, an unfavorable cardiovascular prognosis. Increasing evidence
elucidates that about half of these patients have coronary microvascular
dysfunction (CMD). The current gold standard to diagnose CMD is intracoronary
assessment of coronary flow reserve (CFR), the ratio of the coronary blood flow
at hyperemia as induced by giving intravenous adenosine, to the blood flow at
rest. CFR < 2.5 indicates CMD. However, invasive testing has clear
disadvantages, including the burden for the patients and possible
complications, making it less suitable for routine clinical practice. Coronary
flow reserve can be assessed non-invasively by transthoracic Doppler
echocardiography (TTDE). However, the diagnostic accuracy of this test has only
been evaluated in a couple of small studies that compared TTDE with invasive
CFR by Doppler wire.
Study objective
To assess the diagnostic value and feasibility of CFR measurement by TTDE as
compared to invasive measurement (Gold standard).
Study design
In this cross-sectional study all patients will undergo a TTDE within two
weeks after invasive coronary reactivity testing.
Study burden and risks
TTDE is the only extra test patients will undergo. This is a non-invasive test
with a relatively low burden for the patients. The echocardiography per se is
generally not perceived as a burden. Administration of adenosine can cause side
effects, most frequently chest pain, dyspnea, flushes and headache. Due to the
very short half life of adenosine (<10 sec), these side effects are of short
duration The risk of serious adverse events is extremely low, as explained in
section 8.8.2. The benefit of the availability of a non-invasive test to assess
CFR is substantial. Intracoronary assessment of CFR, the current gold standard
for diagnosis of CMD, has clear disadvantages, including the burden for the
patients and possible complications, making it less suitable for routine
clinical practice. The only way to enhance identification of patients with CMD
and distinguish those at increased cardiovascular risk who might benefit from
medical therapy, is to enable widespread diagnosis by relatively easy and save
tests to detect CMD in daily clinical practice. These tests are not only
essential for widespread diagnosis, but also crucial to evaluate novel
treatment options.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Patients with stable angina will be eligible if their clinically indicated coronary angiogram included a fractional flow reserve (FFR) measurement in the left anterior descending (LAD) artery. Since coronary flow reserve (CFR) is automatically measured together with FFR, invasive CFR measurements are clinically available in these patients.
Exclusion criteria
- Significant coronary stenosis (FFR < 0.8) and/or placement a coronary stent in the LAD after FFR/CFR measurement during the CAG
- History of coronary artery bypass grafts (CABG)
- Unstable angina
- Any contra-indication to provocative stress testing with adenosine
These include:Previous adverse reaction to adenosine, atrial-ventricular blockage (2nd en 3rd degree) and no pacemaker, long QT syndrome, Astma and COPD Gold III or IV
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 | NL53334.091.15 |