Department of Anesthesiology and Intensive Care Medicine, University Hospital of Schleswig-Holstein, Kiel, Germany.
Clinic of Cardiovascular Surgery, University Hospital of Schleswig-Holstein, Campus Kiel, Arnold-Heller-Str. 3, Hs C, 24105, Kiel, Germany.
BMC Cardiovasc Disord. 2022 Aug 4;22(1):353. doi: 10.1186/s12872-022-02795-3.
The best medical treatment (BMT) for most patients with early stage of peripheral arterial occlusive disease (PAOD) is often limited to gait training and pharmacological therapy besides endovascular surgery. The application of remote ischemic conditioning (RIC) has been described as a promising experimental strategy for the improvement of therapeutic outcome in cardiovascular disease but has not proven beneficial effects in clinical practice and treatment of PAOD yet.
Here we describe a prospective, randomized trial for the evaluation of possible effects of repeated application of RIC in patients with PAOD. This monocentric study will enrol 200 participants distributed to an intervention group receiving RIC + BMT and a control group only receiving BMT for four weeks. Patients are at least 18 years of age and have diagnosed PAOD Fontaine stage II b. Pain-free and total walking distance will be measured via treadmill test (primary endpoints). In addition, ankle-brachial index (ABI) and quality of life (QoL) will be assessed using the SF-36 and VascuQoL-6 questionnaire. Moreover, evaluation of markers for atherosclerosis, angiogenic profiling and mononuclear cell characterization will be performed using biochemical assays, proteome profiling arrays and flow cytometry (secondary endpoints).
Our prospective, randomized monocentric trial is the first of its kind to analyse the effects of chronic and repetitive treatment with RIC in patients with PAOD and might provide important novel information on the molecular mechanisms associated with RIC in PAOD patients.
Prospectively registered in the German Clinical Trials Register (Deutsche Register Klinischer Studien) Registration number: DRKS00025735; Date of registration: 01.07.2021.
对于大多数早期外周动脉阻塞性疾病（PAOD）患者，最好的治疗方法（BMT）通常仅限于步态训练和药物治疗，除了血管内手术。远程缺血预处理（RIC）的应用已被描述为改善心血管疾病治疗效果的一种很有前途的实验策略，但尚未在临床实践和 PAOD 治疗中证明其有益效果。
在这里，我们描述了一项评估重复应用 RIC 对 PAOD 患者可能影响的前瞻性、随机试验。这项单中心研究将招募 200 名参与者，分为接受 RIC+BMT 的干预组和仅接受 BMT 治疗 4 周的对照组。患者年龄至少 18 岁，患有诊断为 PAOD Fontaine Ⅱ b 期。将通过跑步机测试测量无疼痛和总步行距离（主要终点）。此外，还将使用 SF-36 和 VascuQoL-6 问卷评估踝肱指数（ABI）和生活质量（QoL）。此外，还将使用生化测定、蛋白质组分析阵列和流式细胞术评估动脉粥样硬化标志物、血管生成分析和单核细胞特征（次要终点）。
我们的前瞻性、随机单中心试验是首例分析慢性和重复 RIC 治疗对 PAOD 患者影响的试验，可能为与 PAOD 患者 RIC 相关的分子机制提供重要的新信息。
在德国临床试验注册处（Deutsche Register Klinischer Studien）前瞻性注册，注册号：DRKS00025735；注册日期：2021 年 7 月 1 日。
