Peripheral Arterial DiseasePADBIRDNCT06373302
Peripheral Arterial Disease Biomarkers
An observational study of Peripheral Arterial Disease, run by Norfolk and Norwich University Hospitals NHS Foundation Trust.
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. Read more about this study
- Who is it for?
- Ages 50 to 99 years
- Conditions the study is for
- Peripheral Arterial Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with peripheral arterial disease
Who may be able to join
- Aged > 50 years
- Symptomatic PAD
- ABPI <0.8 or TBPI <0.7
Who cannot join
- Aged <50 years
- Current Malignancy
- Rheumatological Condition
- Previous surgical or endovascular intervention for PAD
- ABPI >0.8 or TBPI >0.7
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral, Arterial, Disease, Claudication
- Medical subject headings
- Peripheral Arterial Disease, Disease, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Correlation between PAD biomarker levels and walking distance.
The correlation between PAD biomarker levels and walking distance.
Measured: Baseline
Change in PAD biomarker levels following exercise therapy.
To investigate the change in PAD biomarker levels following exercise therapy.
Measured: 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
Measured: 48 hours
Secondary outcomes (3)
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.
Measured: 2 years
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.
Measured: 2 years
Levels of biomarkers and (Major Adverse Cardiovascular Events).
The association between levels of biomarkers and (Major Adverse Cardiovascular Events).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373302
- Sponsor's protocol ID
- IRAS 323948
- Acronym
- PADBIRD
- Status last verified
- Apr 2024
- First submitted
- 11 Dec 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Arterial Disease Biomarkers: The Effect of Intervention on Biomarker Levels and Predictors of Restenosis or Deterioration
- ClinicalTrials.gov ID
- NCT06373302
- Acronym / sponsor ID
- PADBIRD / IRAS 323948
- Conditions
- Peripheral Arterial Disease
- Keywords
- Peripheral, Arterial, Disease, Claudication
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Norfolk and Norwich University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 50 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with peripheral arterial disease
Key inclusion criteria (3 listed)
- Aged > 50 years
- Symptomatic PAD
- ABPI <0.8 or TBPI <0.7
Key exclusion criteria (5 listed)
- Aged <50 years
- Current Malignancy
- Rheumatological Condition
- Previous surgical or endovascular intervention for PAD
- ABPI >0.8 or TBPI >0.7
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between PAD biomarker levels and walking distance.
Time frame: Baseline
The correlation between PAD biomarker levels and walking distance.
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.
Change in PAD biomarker levels following endovascular intervention
Time frame: 48 hours
To investigate the change in PAD biomarker levels following endovascular intervention
3 secondary outcomes
To determine whether biomarker levels normalise with improved walking distance.
Time frame: 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
Levels of biomarkers and (Major Adverse Cardiovascular Events).
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Arterial Disease, run by Norfolk and Norwich University Hospitals NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Phillip Stather (01603 286286, philip.stather@nnuh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between PAD biomarker levels and walking distance. (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.