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

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

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON41333
Enrollment
30
Registered
2013-04-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

atherosclerosis

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - patients scheduled for CAG or Computed Tomography to visualize the coronary arteries - 18 years or older - written informed consent

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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).—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)