Peripheral Arterial Disease Biomarkers

Peripheral Arterial Disease Clinical Trial

— PADBIRD  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06373302
• Other study ID #: IRAS 323948
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: April 2024
• Source: Norfolk and Norwich University Hospitals NHS Foundation Trust
• Contact: Phillip Stather
• Phone: 01603 286286
• Email: philip.stather[@]nnuh.nhs.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Norfolk and Norwich University Hospitals NHS Foundation Trust

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between PAD biomarker levels and walking distance.	The correlation between PAD biomarker levels and walking distance.	Baseline
Primary	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
Primary	Change in PAD biomarker levels following endovascular intervention	To investigate the change in PAD biomarker levels following endovascular intervention	48 hours
Secondary	To determine whether biomarker levels normalise with improved walking distance.	Change in biomarker levels in participants with improved walking distance compared to particicpants with static or deteriorating walking distance at 6 months.	2 years
Secondary	To determine whether biomarker levels can be used as a predictor of restenosis, occlusion or reintervention following endovascular intervention.	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
Secondary	Levels of biomarkers and (Major Adverse Cardiovascular Events).	The association between levels of biomarkers and (Major Adverse Cardiovascular Events).	2 years