Peripheral Arterial Disease Biomarkers

NCT ID: NCT06373302

Last Updated: 2024-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-01

Study Completion Date

2026-12-31

Brief Summary

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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

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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.

Conditions

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Peripheral Arterial Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Exercise Therapy

Patients who are advised by their clinician to undertake exercise therapy as their treatment for peripheral arterial disease

No interventions assigned to this group

Angioplasty

Patients undergoing angioplasty for treatment of peripheral arterial disease, as advised by their clinician.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norfolk and Norwich University Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Phillip Stather

Role: CONTACT

01603 286286

Other Identifiers

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IRAS 323948

Identifier Type: -

Identifier Source: org_study_id

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