The primary objectives of our study are:1. to compare the diagnostic performance of coronary CTA with coronary MRA to detect significant coronary stenoses (> 50% reduction in lumen diameter), in patients with a range of coronary calcium scores,…
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
1. to compare the diagnostic performance of coronary CTA with MRA to detect
significant coronary stenoses (> 50% reduction in lumen diameter), in patients
with a range of coronary calcium scores, using conventional angiography as a
reference standard
Coronary CTA: Significant stenoses (>50% reduction in diameter)
Coronary MRA: Significant stenoses (>50% reduction in diameter)
CAG: Significant stenoses (>50% reduction in diameter)
2. to assess the diagnostic performance of coronary MRA in combination with
perfusion and late enhancement MR imaging to detect hemodynamically significant
stenoses, using FFR and CFR as a reference standard
Coronary MRA, perfusion MR and late enhancement MR imaging: visually decreased
or absent perfusion.
hemodynamically significant stenoses: (1) diameter stenoses >70%, (2) 30-70%
stenoses if the FFR is < 0.8 or CFR < 2
Secondary outcome
-
Background summary
Cardiovascular disease remains the leading cause of morbidity and mortality
worldwide. Coronary computed tomography angiography (CCTA) is currently
preferable to MR angiography (MRA) for ruling out significant coronary artery
disease. Unfortunately, the diagnostic accuracy of CCTA is degraded in the
presence of a high calcium score. Cardiac CMR may improving diagnostic accuracy
in the detection of coronary artery disease.
Study objective
The primary objectives of our study are:
1. to compare the diagnostic performance of coronary CTA with coronary MRA to
detect significant coronary stenoses (> 50% reduction in lumen diameter), in
patients with a range of coronary calcium scores, using conventional coronary
angiography (CAG) as reference standard
2. to assess the diagnostic performance of coronary MRA in combination with
perfusion and late enhancement MR imaging to detect hemodynamically significant
stenoses, using FFR and CFR as a reference standard
Study design
Eighty-five patients scheduled for CAG and fractional flow reserve (FFR) will
undergo a 256-slice coronary CT and cardiac magnetic resonance (CMR) at 1.5
Tesla. The CMR examination will consist of coronary MRA, perfusion MR and late
enhancement MR imaging.
The diagnostic accuracy of CCTA and coronary MRA for the detection of a >50%
reduction in lumen diameter will be determined using CAG as the reference
method. Furthermore, the CMR examination will be compared against FFR and
coronary flow reserve (CFR). FFR and CFR will be measured in all vessels with
40-70% severity stenosis. FFR < 0.80 and CFR < 2.0 will be considered
hemodynamically significant.
Study burden and risks
In this study patients will undergo a coronary CT scan and a cardiac MR scan.
For any risk associated with the use of contrast all necessary precautions
will be taken (see E7/E9). The radiation dose of the coronary CT is very
limited. Although the radiation dose is higher than the maximum recommended
annual dose for the general population it doesn't exceed the dose limit that
applies to those working with X-rays. Furthermore, no adverse effects are known
of 1.5 Tesla MRI. The burden associated with participation is justified given
the importance of improved diagnosis in patients with atherosclerosis and in
the future the possibility for better treatment.
Heidelberglaan 100
3584 CX Utrecht
NL
Heidelberglaan 100
3584 CX Utrecht
NL
Listed location countries
Age
Inclusion criteria
- patients scheduled for coronary angiography (CAG)in combination with fractional flow reserve (FFR)/ coronary flow reserve (CFR) measurements
- 18 years or older
- signed, written informed consent
Exclusion criteria
- acute coronary syndrome
- atrial fibrillation
- previous coronary bypass graft surgery
- previous myocardial infarction
- impaired left ventricular (LV) function (ejection fraction < 40%),
- obstructive pulmonary disease
- pregnancy or possible pregnancy
- lactation
- documented allergic reaction to gadolinium or iopromide
- subjects with impaired renal function (severe renal insufficiency, GFR < 30 ml/min/1.73m2)
- impossibility to undergo a MRI scan (determined by using the standard contraindications for MR imaging as used for clinical purposes)
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 | NL37846.041.11 |