Peripheral Arterial Disease Biomarkers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peripheral Arterial Disease. Basic parameters: 50 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Peripheral Arterial Disease Biomarkers: The Effect of Intervention on Biomarker Levels and Predictors of Restenosis or Deterioration
Overview
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.
Primary outcome measures
- Correlation between PAD biomarker levels and walking distance. [Time frame: Baseline]
- Change in PAD biomarker levels following exercise therapy. [Time frame: 6 months up to 2 years]
- Change in PAD biomarker levels following endovascular intervention [Time frame: 48 hours]
Secondary outcome measures (3)
- To determine whether biomarker levels normalise with improved walking distance. [Time frame: 2 years]
- To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention. [Time frame: 2 years]
- Levels of biomarkers and (Major Adverse Cardiovascular Events). [Time frame: 2 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06373302 · IRAS 323948