Peripheral Arterial Disease Biomarkers: The Effect of Intervention on Biomarker Levels and Predictors of Restenosis or Deterioration
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Correlation between PAD biomarker levels and walking distance.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 50 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged > 50 years
- •Symptomatic PAD
- •ABPI <0.8 or TBPI <0.7
排除标准
- •Aged <50 years
- •Current Malignancy
- •Rheumatological Condition
- •Previous surgical or endovascular intervention for PAD
- •ABPI >0.8 or TBPI >0.7
结局指标
主要结局
Correlation between PAD biomarker levels and walking distance.
时间窗: Baseline
The correlation between PAD biomarker levels and walking distance.
Change in PAD biomarker levels following endovascular intervention
时间窗: 48 hours
To investigate the change in PAD biomarker levels following endovascular intervention
Change in PAD biomarker levels following exercise therapy.
时间窗: 6 months up to 2 years
To investigate the change in PAD biomarker levels following exercise therapy.
次要结局
- Levels of biomarkers and (Major Adverse Cardiovascular Events).(2 years)
- 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)