Peripheral Arterial Disease Biomarkers

NCT06373302 | Not Yet Recruiting

• 1 other identifier: IRAS 323948
• Study Type: observational
• Target: 100
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Peripheral Arterial Disease

Keywords

Peripheral; Arterial; Disease; Claudication

Outcome Measures

Primary Outcomes (3)

• Correlation between PAD biomarker levels and walking distance.

  The correlation between PAD biomarker levels and walking distance.

  Baseline

• Change in PAD biomarker levels following exercise therapy.

  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

  To investigate the change in PAD biomarker levels following endovascular intervention

  48 hours

Secondary Outcomes (3)

• 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

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

  2 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral arterial disease

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead

MeSH Terms

Conditions

Peripheral Arterial Disease; Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Phillip Stather

CONTACT

01603 286286; philip.stather@nnuh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: April 18, 2024
• Study Start: May 1, 2024
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share