Accuracy of 7T contrast-enhanced Magnetic Resonance Angiography for the assessment of coronary artery stenoses: a pilot study

Withdrawn

• Conditions: atherosclerosis; 10011082; 10003216

• Registration Number: NL-OMON41333
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 30

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)

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The presence of significant narrowing of the coronary arteries (>50% reduction<br /><br>in diameter) on 7T CE-MRA. The conventional CAG or CT scan will be used as<br /><br>reference standard. Sensitivity, specificity, positive predictive value (PPV),<br /><br>negative predictive value (NPV), and accuracy per patient, vessel, and segment<br /><br>analysis will be calculated with a 95% confidence interval (CI). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>not applicable</p><br>