Effect of Different Treatment Strategies on Mitochondrial Function in Peripheral Arterial Disease - a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change of near infrared spectroscopy
研究概览
简要总结
The aim of this study is to investigate the effect of different treatment strategies on mitochondrial function and to correlate in-vitro results to findings from in-vivo measurements of mitochondrial function. The authors hypothesize that interventional revascularization and therefore the restoration of blood and oxygen supply is more relevant to mitochondrial function compared to the effect of exercise training.
详细描述
Resulting from a chronic narrowing of arteries by atherosclerotic lesions, the leading clinical symptom of peripheral arterial disease (PAD), a walking induced pain, reduces quality of life of patients. Affected muscle regions are altered by a characterized myopathy and mitochondria are known to play a crucial role in this pathophysiological mechanism. There are different methodological approaches to investigate mitochondrial function in-vivo as well as in-vitro. Regarding our own preliminary data, mitochondria are known to recover after successful revascularization. The effect of different treatment strategies on mitochondrial function and the correlation of in-vitro to clinical more applicable in-vivo methods was understudied so far.
The overall aim of this study is to investigate the effect of different treatment strategies on mitochondrial function and to correlate in-vitro results to findings from in-vivo measurements of mitochondrial function. The authors hypothesize that interventional revascularization and therefore the restoration of blood and oxygen supply is more relevant to mitochondrial function compared to the effect of exercise training.
Patients with isolated pathologies of the superficial femoral artery and symptomatic PAD (Fontaine stage IIB) will be included and randomized to different treatment groups (conservative treatment versus interventional revascularization). Near-infrared refracted spectroscopy and the TIVITA ® hyperspectral camera will be used for in-vivo measurement of peripheral oxygen saturation and distal perfusion before and after an exercise. Muscle biopsies will be obtained from affected (gastrocnemius muscle) as well as from unaffected muscle (lateral vastus muscle) shortly before and 12 weeks after initiating treatment. Muscle samples will be investigated by measurement of CSA regarding mitochondrial content and HRR regarding mitochondrial respiration as well as for oxidative stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Isolated flow limiting arteriosclerotic lesion of the superficial femoral artery
- •Unilateral grade II b (Fontaine) peripheral arterial disease
- •Informed consent
排除标准
- •Flow limiting arteriosclerotic lesions of the infrarenal aorta, iliac arteries or common/ deep femoral artery
- •Contraindication for exercise therapy
研究组 & 干预措施
Healthy control group
Patients undergoing surgery for symptomatic varicose veins with excluded PAD will serve as a control group.
Exercise group
Patients with intermittent claudication will receive conservative treatment with monitored exercise training for a total of 12 weeks (home-based training, minimum of three times a week, documented by using a diary with documentation of the type, the intensity and the duration of the training as well as by using a physical activity monitoring system (Move 4, Karlsruhe, Germany).
干预措施: Exercise therapy (Other)
Revascularization group
will receive revascularization of the underlying atherosclerosis lesion of the superficial femoral artery. Depending on the exact morphology of the lesion, patients with short superficial femoral artery lesions (<25 cm) will be subdivided into group 2A with endovascular treatment and patients with long superficial femoral artery lesions (>25 cm) will be subdivided into group 2B with open surgical treatment
干预措施: Revascularization (Procedure)
结局指标
主要结局
Change of near infrared spectroscopy
时间窗: After 12 weeks - compared to baseline at inclusion
Near infrared spectroscopy measurement of calf
Change in mitochondrial function after defined treatment
时间窗: After 12 weeks - compared to baseline at inclusion
High-resolution respirometry of muscle biopsy sample
次要结局
- Change in standardized 6-minutes walking test(After 12 weeks - compared to baseline at inclusion)
- Change in ankle-brachial index(After 12 weeks - compared to baseline at inclusion)
- Change in flow mediated dilation of the brachial artery(After 12 weeks - compared to baseline at inclusion)