Peripheral Arterial Disease Biomarkers

Not yet recruiting

• Conditions: Peripheral Arterial Disease

• Registration Number: NCT06373302
• Lead Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust

Brief Summary

The study aims to determine how expression levels of biomarkers for peripheral arterial disease change over time in response to exercise therapy, surgical or endovascular intervention, and whether they can be used to predict disease progression.

Detailed Description

Several studies have identified markers in the blood (called biomarkers) that are associated with peripheral arterial disease, or clogging up of the blood supply to the leg. There is little understanding however regarding how these respond to intervention, and how they are related to walking distance.

This study will increase the understanding of the relationship between peripheral arterial disease state and biomarker expression and enable us to work towards the development of new targets for treatment.

Participants will be invited to undertake questionnaires and dedicated walking tests alongside regular blood tests to check their biomarker levels. These will be undertaken on a regular basis so the investigators can see what happens over time, such as after a surgical procedure, and see if these markers go back towards normal following intervention.

Study Timeline

• Study First Submitted: 2023-12-11
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-17
• Last Update Submitted: 2024-04-17
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Study Start: 2024-05-01
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Aged > 50 years
• Symptomatic PAD
• ABPI <0.8 or TBPI <0.7

Exclusion Criteria

• Aged <50 years
• Current Malignancy
• Rheumatological Condition
• Previous surgical or endovascular intervention for PAD
• ABPI >0.8 or TBPI >0.7

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Correlation between PAD biomarker levels and walking distance.	Baseline	The correlation between PAD biomarker levels and walking distance.
Change in PAD biomarker levels following endovascular intervention	48 hours	To investigate the change in PAD biomarker levels following endovascular intervention
Change in PAD biomarker levels following exercise therapy.	6 months up to 2 years	To investigate the change in PAD biomarker levels following exercise therapy.

Secondary Outcome Measures

Name	Time	Method
Levels of biomarkers and (Major Adverse Cardiovascular Events).	2 years	The association between levels of biomarkers and (Major Adverse Cardiovascular Events).
To determine whether biomarker levels normalise with improved walking distance.	2 years	Change in biomarker levels in participants with improved walking distance compared to particicpants with static or deteriorating walking distance at 6 months.
To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention.	2 years	Compare the change in biomarkers levels pre and post angioplasty between participants requiring reintervention or occlusion, and those not requiring re-intervention or occlusion.