Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06391346
Status:
RECRUITING
Last Update Posted:
2024-04-30
First Post:
2024-02-20
Brief Title:
Investigation of the Perfusion of Gluteal Muscle in Patients With Intermittent Gluteal Claudication by Non-invasive MSOT
Sponsor:
Ulrich Rother
Organization:
University Hospital Erlangen
Study Overview
Official Title:
Evaluation of Gluteal Muscle Perfusion in Patients With Intermittent Gluteal Claudication by Non-invasive Multispectral Optoacoustic Tomography With Pre-post Study Design
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of the proposed study is to define independent parameters for the diagnostic assessment of the perfusion situation of the gluteal muscle based on multispectral optoacoustic tomography MSOT in patients with gluteal claudication in Fontaine stage II intermittent claudication pre and post-intervention
Detailed Description:
This is a monocentric prospective study which aims to exanimate the optoacoustic signals in gluteal muscle after a exercise in patients with PAD in Fontaine stage II before and after the revascularisation to verify the change of MSOT by improved vascularization MSOT data will be correlated with CCDS ABI treadmill test subjectively perceived absolute walking distance in everyday life PAD-related life quality VASCUQOL-6 and TASC II classification in angiographic imaging only in case angiographic imaging is available and independent from this study
Patients with gluteal claudication in Fontaine stage II will be recruited during the consulting hours of the Department of Vascular Surgery University Hospital Erlangen Following detailed information about the study and after providing written consent relevant clinical data will be collected from the electronical patient file if available In addition a thorough anamnesis interview for relevant data and CCDS would be performed Afterwards the MSOT parameters will be recorded on gluteal muscles before and after a stepper exercise two minutes or until the occurrence of claudication pain in the gluteal muscle The more affected side is examined All data will be adequately pseudonymized in compliance with data protection regulations before they are used for statistical analysis The duration of the study for participants will be max 90 minutes The angiographic imaging will be reviewed and analyzed
Patients with gluteal claudication in Fontaine stage II will be recruited during the consulting hours of the Department of Vascular Surgery University Hospital Erlangen Following detailed information about the study and after providing written consent relevant clinical data will be collected from the electronical patient file if available In addition a thorough anamnesis interview for relevant data and CCDS would be performed Afterwards the MSOT parameters will be recorded on gluteal muscles before and after a stepper exercise two minutes or until the occurrence of claudication pain in the gluteal muscle The more affected side is examined All data will be adequately pseudonymized in compliance with data protection regulations before they are used for statistical analysis The duration of the study for participants will be max 90 minutes The angiographic imaging will be reviewed and analyzed
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None