The purpose of the study is to assess the diagnostic accuracy of a combined use of non-invasive coronary angiography with multi-slice computed tomography (MSCT) and stress cardiac magnetic resonance (CMR) imaging in patients with obstructive lesions…
ID
Source
Brief title
Condition
- Coronary artery disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The diagnostic accuracy of MSCT coronary angiography in combination with stress
CMR imaging as compared to invasive CAG and FFR measurement, as a standard of
reference to detect obstructive and hemodynamically significant stenoses in
patients with low to intermediate pre-test likelihood of CAD will be
investigated.
Secondary outcome
The ability of combined use of MSCT coronary angiography and stress CMR imaging
to predict treatment strategy (medical therapy versus revascularization
therapy) as compared to CAG and FFR will be determined.
Background summary
It has been demonstrated in previous studies that there is a discrepancy
between the coronary artery stenosis severity and its hemodynamic significance.
Moreover, data are available that only lesions with hemodynamic significance
may be appropriate to treat with revascularization. Accordingly, the ability to
detect hemodynamically significant lesions is clinically relevant. Multi-slice
computed tomography (MSCT) allows non-invasive detection of coronary artery
stenoses, whereas stress cardiac magnetic resonance (CMR) imaging allows
non-invasive visualisation of myocardial ischemia.
Study objective
The purpose of the study is to assess the diagnostic accuracy of a combined use
of non-invasive coronary angiography with multi-slice computed tomography
(MSCT) and stress cardiac magnetic resonance (CMR) imaging in patients with
obstructive lesions on MSCT and with low to intermediate pre-test likelihood of
coronary artery disease (CAD) as compared to invasive coronary angiography
(CAG) and Fractional Flow Reserve (FFR) measurements.
Study design
Multi-center prospective study.
Study burden and risks
Based on currently available clinical evidence, risks related to the devices
used in this study are comparable to standard equipment used. Dual source MSCT
is performed in routine clinical practice and is considered as a safe,
non-invasive investigation, although it involves administration of contrast
medium, and the use of radiation. Accordingly, only patients with good kidney
function and with no prior history of allergy to contrast agents will be
included in the study. The MSCT protocols with the least possible radiation
exposure will be applied, so that exposure favourably compares to other
non-invasive imaging modalities (such as myocardial perfusion scintigraphy).
For stress CMR imaging, gadolinium contrast agent and adenosine administration
will be required. Accordingly patients with known contraindications to one of
these agents will not be eligible for participation.
Similarly, administration of adenosine is necessary for the FFR measurements.
Accordingly, patients with contraindications for adenosine will not be included
in the study.
Hanzeplein 1
Groningen 9700 RB
NL
Hanzeplein 1
Groningen 9700 RB
NL
Listed location countries
Age
Inclusion criteria
1.Patients with stable angina pectoris with low to intermediate pre-test likelihood of CAD;
2.no previous history of CAD;
3.obstructive stenosis (*50% luminal narrowing) on MSCT coronary angiography;
4.informed consent.
Exclusion criteria
1.patients with a previous history of CAD;
2.patients with contraindications for MSCT:
a.cardiac rhythms other than sinus rhythm,
b.pregnancy,
c.allergy for contrast medium,
d.renal failure (estimated glomerular filtration rate (eGFR) < 50ml/min),
e.resting heart rate >75 bpm plus contra-indications for beta-blockade,
f. weight >100 kilograms;
3. contraindications for cardiac magnetic resonance (CMR) imaging:
a.MR-incompatible implants,
b. Claustrophobia,
c. contraindications for adenosine:
i. known or suspected hypersensitivity to adenosine,
ii. known or suspected bronchoconstrictive or bronchospastic disease,
iii. 2nd or 3rd degree atrioventricular (AV) block,
iv. Sinus bradycardia (heart rate < 45 bpm),
v. Systemic arterial hypotension (<90 mmHg).
d. contraindications for gadolinium:
i. renal failure (estimated eGFR <30 ml/min);
4. no informed consent.
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 | NL36359.042.11 |