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Critical Limb Ischemia: MRA And CTA Study (Feasibility)

Critical Limb Ischemia: MRA And CTA Study (Feasibility) - CLIMACS-F

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON37452
Enrollment
10
Registered
2012-04-12
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

critical limb ischemia severe peripheral vascular disease

Interventions

None listed

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Critical limb ischemia > 2 weeks ankle-brachial pressure index 60 ml/min Written informed consent

Exclusion criteria

Exclusion criteria: Inability to give informed consent Contraindications for MRI, i.e. metal implants or claustrophobia Contraindications for CTA, i.e. allergic reactions to iodinated contrast agents, hyperthyroidism, goiter or pregnancy Patient participates in another study

Design outcomes

Primary

MeasureTime frame
The main study parameter is the burden for the patient of CTA and MRA expressed as the score of the visual analogue scale (VAS) and on a 5-point Likert scale.

Secondary

MeasureTime frame
The diagnostic accuracy of CTA and MRA to identify arterial stenoses > 50% and occlusions in patients with CLI will be compared to DSA as the reference standard. Interobserver agreement for grading arterial stenosis and occlusions with CTA and MRA in patients with CLI will be expressed as weighted *-values. The correlation between arterial calcifications and the diagnostic accuracy of CTA and MRA to identify arterial stenosis and occlusion in patients with CLI will be evaluated.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)