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临床试验/NCT07087522
NCT07087522尚未招募不适用

Impact of Preprocedural Stress Ball Use on Radial Artery Outcomes in Elective Coronary Angiography: A Randomized Controlled Trial

Sakarya University2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
400
试验地点
2
主要终点
Radial Artery Spasm Rate

研究概览

简要总结

This randomized, double-blind, controlled trial aims to evaluate the effect of preprocedural hand exercise using a stress ball on the incidence of radial artery spasm and other vascular complications in patients undergoing elective coronary angiography via the transradial approach. A total of 400 adult patients scheduled for elective diagnostic or interventional coronary procedures will be randomly assigned to either an intervention group (preprocedural stress ball exercise) or a control group (standard care). The intervention group will perform hand exercises with a soft stress ball for 5 minutes, three times daily, for three consecutive days prior to the procedure.

The primary outcomes are the incidence of radial artery spasm during the procedure and the overall rate of radial artery complications.

Secondary outcomes include patient-reported pain score (visual analog scale) during the procedure and the incidence of radial artery occlusion at 7 days, assessed by Doppler ultrasonography.

This study aims to determine whether this simple, low-cost strategy can reduce radial artery-related complications and improve patient comfort during transradial coronary procedures.

详细描述

Radial artery access has become the preferred approach for coronary angiography and percutaneous coronary intervention (PCI) due to its superior safety profile, reduced bleeding complications, earlier patient mobilization, and improved overall comfort compared to the traditional femoral approach. Despite these advantages, transradial procedures are not entirely free of complications. Radial artery spasm (RAS) remains a significant concern, with reported incidence rates ranging from 4% to 20%, depending on operator experience and patient-related factors. Additionally, vascular complications such as hematoma, arterial dissection, pseudoaneurysm, bleeding at the access site, and post-procedural radial artery occlusion (RAO) can affect procedural success and may limit future access via the same route.

Handgrip exercise has been proposed as a simple, non-invasive, and cost-effective strategy to improve arterial compliance, increase vessel diameter, and potentially reduce vasospasm by enhancing endothelial function and promoting local vasodilation. Despite promising physiologic rationale and preliminary findings in other settings (such as arterial diameter augmentation prior to AV fistula creation), the role of preprocedural hand exercise in preventing radial artery complications during coronary procedures has not been systematically studied in a randomized controlled trial.

This single-center, randomized, double-blind, controlled clinical trial aims to assess whether regular preprocedural hand exercise using a soft stress ball can reduce the incidence of RAS and vascular complications in patients undergoing elective coronary angiography via the transradial approach.

A total of 400 adult patients (aged 18 to 85 years), scheduled for elective diagnostic or interventional coronary procedures via the radial artery, will be enrolled. Patients with contraindications to radial access, prior significant upper limb vascular disease, or inability to perform the hand exercise regimen will be excluded.

Participants will be randomly assigned in a 1:1 ratio to either the intervention group or the control group using a computer-generated randomization sequence. Both the interventional cardiologist performing the procedure and the clinical staff responsible for outcome assessment will remain blinded to group allocation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Care Provider, Outcomes Assessor)

盲法说明

Both the interventional cardiologist performing the radial procedure and the outcome assessor conducting the Doppler ultrasonography will be blinded to the participant's group allocation. This double-blind design aims to minimize procedural and assessment bias.

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 and 85 years
  • Elective radial coronary angiography planned
  • Written informed consent provided
  • Ability to understand and comply with the stress ball exercise protocol (3×5 minutes/day for 3 days prior to procedure)
  • Palpable radial pulse on the planned access site

排除标准

  • Emergent or urgent coronary procedures
  • Known radial artery occlusion or non-palpable radial pulse on the intended access side
  • Prior arteriovenous fistula or vascular surgery in the ipsilateral arm
  • History of Raynaud's disease, severe peripheral artery disease, or Buerger's disease
  • Neurological or musculoskeletal disorders affecting hand grip (e.g., stroke, advanced arthritis, peripheral neuropathy)
  • Cognitive impairment or psychiatric condition preventing protocol adherence
  • Inability to use hand muscles effectively (e.g., recent hand trauma, paralysis)
  • Unwillingness or inability to perform the stress ball exercises as instructed
  • Pregnancy or breastfeeding

结局指标

主要结局

Radial Artery Spasm Rate

时间窗: Periprocedural

Incidence of periprocedural radial artery spasm as reported by the operator, characterized by catheter resistance, patient discomfort, or vasodilator need.

Pain Score During Procedure (VAS)

时间窗: Immediately after the procedure

Visual Analog Scale (VAS) score reported by the patient (0 = no pain, 10 = worst pain imaginable).

次要结局

  • Radial Artery Occlusion (RAO)(7 days after the procedure)
  • Radial Artery Cannulation Duration(During radial artery cannulation procedure)
  • Number of Puncture Attempts(During radial artery cannulation procedure)

研究者

发起方
Sakarya University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emre Eynel, MD

Dr. Emre Eynel, Specialist in Cardiology

Sakarya University

研究点 (2)

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