Peripheral Arterial Disease Biomarkers
ConditionPeripheral Arterial Disease
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-99
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Aged > 50 years
Symptomatic PAD
ABPI <0.8 or TBPI <0.7
Disqualifiers
Aged <50 years
Current Malignancy
Rheumatological Condition
Previous surgical or endovascular intervention for PAD
Trial population
Patients with peripheral arterial disease
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: Exercise Therapy
Group B: Angioplasty
Trial outcomes
Primary outcomes
1
Correlation between PAD biomarker levels and walking distance.
The correlation between PAD biomarker levels and walking distance.
Time frame
Baseline2
Change in PAD biomarker levels following exercise therapy.
To investigate the change in PAD biomarker levels following exercise therapy.
Time frame
6 months up to 2 years3
Change in PAD biomarker levels following endovascular intervention
To investigate the change in PAD biomarker levels following endovascular intervention
Time frame
48 hoursSecondary outcomes
1
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.
Time frame
2 years2
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.
Time frame
2 years3
Levels of biomarkers and (Major Adverse Cardiovascular Events).
The association between levels of biomarkers and (Major Adverse Cardiovascular Events).
Time frame
2 yearsLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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