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NCT Number: NCT06373302

Peripheral Arterial Disease Biomarkers

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Disease Intermittent Claudication Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Vascular Diseases Signs and Symptoms Vascular Diseases

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Correlation between PAD biomarker levels and walking distance.

    Time frame: Baseline

    The correlation between PAD biomarker levels and walking distance.

  2. 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.

  3. Change in PAD biomarker levels following endovascular intervention

    Time frame: 48 hours

    To investigate the change in PAD biomarker levels following endovascular intervention

Secondary outcomes

  1. To determine whether biomarker levels normalise with improved walking distance.

    Time frame: 2 years

    Change in biomarker levels in participants with improved walking distance compared to particicpants with static or deteriorating walking distance at 6 months.

  2. To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention.

    Time frame: 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.

  3. Levels of biomarkers and (Major Adverse Cardiovascular Events).

    Time frame: 2 years

    The association between levels of biomarkers and (Major Adverse Cardiovascular Events).

Study contacts

Contact information is provided by the study sponsor or research team.

Phillip Stather

CONTACT

[email protected]

01603 286286

Sponsors and collaborators

Lead sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Other

Registry information

Official study title

Peripheral Arterial Disease Biomarkers: The Effect of Intervention on Biomarker Levels and Predictors of Restenosis or Deterioration

Acronym: PADBIRD

Important dates

Study start
2024
Primary completion
2024
Study completion
2026
First posted
Apr 18, 2024
Registry last updated
Apr 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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