Peripheral Arterial Disease Biomarkers: The Effect of Intervention on Biomarker Levels and Predictors of Restenosis or Deterioration
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peripheral Arterial Disease
- Sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Enrollment
- 100
- Primary Endpoint
- Correlation between PAD biomarker levels and walking distance.
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Correlation between PAD biomarker levels and walking distance.
Time Frame: Baseline
The correlation between PAD biomarker levels and walking distance.
Change in PAD biomarker levels following endovascular intervention
Time Frame: 48 hours
To investigate the change in PAD biomarker levels following endovascular intervention
Change in PAD biomarker levels following exercise therapy.
Time Frame: 6 months up to 2 years
To investigate the change in PAD biomarker levels following exercise therapy.
Secondary Outcomes
- Levels of biomarkers and (Major Adverse Cardiovascular Events).(2 years)
- To determine whether biomarker levels normalise with improved walking distance.(2 years)
- To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention.(2 years)