The objective of this study is to assess the diagnostic performance of Ultra-high field 7 Tesla (T) MRA to detect significant coronary stenoses.
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
The presence of significant narrowing of the coronary arteries (>50% reduction
in diameter) on 7T CE-MRA. The conventional CAG or CT scan will be used as
reference standard. Sensitivity, specificity, positive predictive value (PPV),
negative predictive value (NPV), and accuracy per patient, vessel, and segment
analysis will be calculated with a 95% confidence interval (CI).
Secondary outcome
not applicable
Background summary
Cardiovascular disease is the leading cause of morbidity and mortality
worldwide. Contrast Enhanced Magnetic Resonance Angiography (CE-MRA) is able to
visualize the coronary arteries in a non-invasive way. The use of Ultra-high
field CE-MRA may increase the diagnostic performance to detect significant
coronary artery stenoses.
Study objective
The objective of this study is to assess the diagnostic performance of
Ultra-high field 7 Tesla (T) MRA to detect significant coronary stenoses.
Study design
This study is designed as a cross-sectional diagnostic study.
Study burden and risks
There are minimal risks regarding the use of gadolinium contrast. All
participants will be screened on allergy for contrast agents and the renal
function will be evaluated.
Furthermore, no short or long term adverse effects of the MRI scanners on the
human body are known.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- patients scheduled for CAG or Computed Tomography to visualize the coronary arteries
- 18 years or older
- written informed consent
Exclusion criteria
- acute coronary syndrome
- atrial fibrillation
- pregnancy or possible pregnancy
- lactation
- documented allergic reaction to gadolinium
- 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 | NL42681.041.12 |