Upper Extremity Dysfunction Post Radial PCI: A Cohort Study Evaluating Upper Extremity Dysfunction After Percutaneous Coronary Intervention Using the Radial Artery as Access Route
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- A binary score of upper extremity dysfunction
研究概览
简要总结
Trans-Radial Percutaneous Coronary Intervention (TR-PCI) is rapidly becoming the gold standard. This is especially the case in primary Percutaneous Coronary Interventions (PCI), where most benefits of the radial approach, such as reduced major bleeding and mortality, can be expected. However there is very limited research available looking at the consequences of trans-radial access for upper extremity function.
The main objective of this study is to provide insight in the morbidity with regards to the upper extremity surrounding the radial access route in percutaneous coronary interventions. Secondary objectives are to provide insight in the consequences for functional status, factors influencing and financial costs of this morbidity, to identify subject who might benefit from early referral and treatment of this morbidity and to generate hypotheses for further clinical research into this matter.
The investigators hypothesis is that approximately 20% of the population will experience upper extremity dysfunction after TR-PCI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Presenting for TR-PCI at the study centre.
- •The radial artery can be palpated and Doppler ultrasound examination of the radial artery shows non-occlusive flow.
排除标准
- •Currently enrolled in another study that clinically interferes with this study and that has not passed the primary endpoint.
- •The clinical condition prohibits or hinders informed consent and/or baseline examinations. E.g. cardiogenic shock and cardiopulmonary resuscitation or subconscious and semiconscious state,.
- •Co-morbid condition(s) that could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific integrity of the study, e.g. loss of voluntary motor control of the studied extremities.
结局指标
主要结局
A binary score of upper extremity dysfunction
时间窗: 2 weeks
A positive score is defined as the presence of at least a ≥1 point increase in the Levine-Katz (Boston) questionnaire; or at least 2 of the following decreased scores compared to baseline, 2 weeks after TR-PCI: * ≥15% decrease in the DASH-outcome measure. * Increase in VAS pain score with regard to the upper extremity of ≥2 points * Absent signal of the radial artery using Doppler * 10% decrease in goniometry of the upper extremity, with a minimum decrease of 10 degree Strength * 60N decrease in palmar grip strength * 12N decrease in pinch grip strength * 15% decrease in isometric strength of the following manoeuvres: * Flexion and extension of the elbow and/or wrist * Sensibility loss of ≥1 filament of the hand using Semmes-Weinstein filaments according to WEST * 1cm increase at volumetry of the hand, using the Figure of 8-method * 1cm increase at volumetry of the forearm, measured circumferentially 8 cm distal of the medial epicondyle * Compartment syndrome
次要结局
- Radiation(During procedure)
- Anomaly(During procedure)
- Catheter performance(During procedure)
- AROM(6 months)
- Strength(6 months)
- VAS(6 months)
- Cross-over(During procedure)
- Procedural success(During procedure)
- Procedure time(During procedure)
- Successful arterial access(During procedure)
- Access route complications(6 months)
- MACCE(6 months)
- Sensibility(6 months)
- Volumetry of the hand(6 months)
- Levine-Katz (Boston) questionnaire(6 months)
- DASH(6 months)
- Volumetry of the forearm(6 months)
- Bleeding(6 months)
- Occlusion(6 months)
研究者
Anna Koopman
MD
Albert Schweitzer Hospital