Magnetic resonance Imaging techniques in patients with Refractory Critical Limb ischemia

Magnetic resonance Imaging techniques in patients with Refractory Critical Limb ischemia - MIRaCLe study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON44605

Enrollment

Registered

2018-01-15

Start date

2018-05-17

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

CLI PAD

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Informed consent Age >= 16 years Ability to lie still for 15 minutes without rest pain.

Exclusion criteria

Exclusion criteria: Acute limb ischemia Earlier bypass surgery at the side of imaging Any intravascular stent in the femoral artery at the side of imaging MR related exclusion criteria

Design outcomes

Primary

Measure	Time frame
Primary endpoints are: • Signal-to-noise ratio (SNR) for each MRI technique. SNR of the MRI image and the SNR of the derived perfusion graphs. • Inter observer calculations of the two MRI techniques. Intraclass correlation coefficient (ICC) is calculated for two observers both independently delineating regions of interests for calculation of perfusion graphs. • Discriminative value - calculation of correlation values of measurement and image parameters with the three study groups (Spearman correlation).	—

Measure

Time frame

Primary endpoints are: • Signal-to-noise ratio (SNR) for each MRI technique. SNR of the MRI image and the SNR of the derived perfusion graphs. • Inter observer calculations of the two MRI techniques. Intraclass correlation coefficient (ICC) is calculated for two observers both independently delineating regions of interests for calculation of perfusion graphs. • Discriminative value - calculation of correlation values of measurement and image parameters with the three study groups (Spearman correlation).

—

Secondary

Measure	Time frame
To assess the level of discomfort of the different techniques in patients with and without critical ischemia.	—

Countries

Netherlands

Outcome results