Peripheral Arterial Disease Biomarkers (PADBIRD)

April 17, 2024 updated by: Norfolk and Norwich University Hospitals NHS Foundation Trust

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Peripheral Arterial Disease

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Phillip Stather
Phone Number: 01603 286286
Email: philip.stather@nnuh.nhs.uk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Patients with peripheral arterial disease

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Exercise Therapy Patients who are advised by their clinician to undertake exercise therapy as their treatment for peripheral arterial disease
Angioplasty Patients undergoing angioplasty for treatment of peripheral arterial disease, as advised by their clinician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between PAD biomarker levels and walking distance. Time Frame: Baseline	The correlation between PAD biomarker levels and walking distance.	Baseline
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.	6 months up to 2 years
Change in PAD biomarker levels following endovascular intervention Time Frame: 48 hours	To investigate the change in PAD biomarker levels following endovascular intervention	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 years
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.	2 years
Levels of biomarkers and (Major Adverse Cardiovascular Events). Time Frame: 2 years	The association between levels of biomarkers and (Major Adverse Cardiovascular Events).	2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

December 11, 2023

First Submitted That Met QC Criteria

April 17, 2024

First Posted (Actual)

April 18, 2024

Study Record Updates

Last Update Posted (Actual)