跳至主要内容
临床试验/NCT01984411
NCT01984411已完成3 期

Comparison of Vascular ACcess for Radial and Femoral Completion of Diagnostic Cardiac Catheterization Performed at the Clinic Patients Northern General de Barranquilla in 2013. Controlled Clinical Trial of Non-inferiority

Centro Cardiológico del Caribe, Columbia1 个研究点 分布在 1 个国家目标入组 220 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
220
试验地点
1
主要终点
Minutes Total Procedure Time

研究概览

简要总结

Cardiac catheterization is the most important test for the evaluation of cardiac patients. Since the beginning of the cardiac catheterization procedure, we have used the femoral artery puncture as a gateway for those procedures. Recently it is used more often the path for the radial. Using this approach has gained many followers worldwide and has been used almost routinely in our country but has not gained popularity because many interventional cardiologists argue that the transradial procedure is much more time-consuming and difficult.

Research question: Are there differences in the total procedure time path between radial and femoral vascular to perform cardiac catheterizations?.

This research focuses on the search for information to determine whether there are significant differences when the variables under study. This research is justified by the need to evaluate the two techniques in use and the lack of studies evaluating and comparing the radial arterial access in comparison with femoral access route which is widely used in all services hemodynamics national and international. The lack of research on the subject has made the use of the transradial procedure routinely not being done, because they have the idea that it is much more time-consuming and technically more difficult than the procedure performed by the femoral approach, hence Hemodynamics specialists, not everyone wants to start implementing the systematic use of the radial approach for cardiac catheterization studies.The main objective of this project is to determine the non-inferiority in terms of total procedure time path between radial and femoral vascular to perform cardiac catheterizations. Secondary objectives: the difference in time of puncture, duration of the procedure and recovery. Incidence of vascular complications and techniques between radial and femoral, presence of complications at 8 days of follow-up. Our aims to check through the results, if the difference in each of the variables favoring either of the two techniques and to determine the non-inferiority of one technique over the other in terms of ease and effectiveness of both procedures. The type of study is a controlled clinical trial open, randomized, non-inferiority. The study population will consist of patients who have been told the diagnostic cardiac catheterization, they are sent to the General Clinic Northern institution.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients over 18 years
  • Patients requiring a performing diagnostic cardiac catheterization procedure, scheduled electively or urgently,
  • Patients mentally healthy
  • Patients with test Allen (palmar arch patency) normal
  • Patients who signing the informed consent.

排除标准

  • Patients with a history of allergic reaction to the dye.
  • Patients with peripheral vascular disease.
  • Anticoagulated patients with coumarinic or other oral anticoagulants.
  • Patients with arteriovenous fistula for hemodialysis.
  • Patients with a history of coronary artery bypass surgery.
  • Patients with amputations or upper limb deformities.
  • Patients with limited movement in the upper limbs or burns contractures.
  • Patients requiring catheterization while the right heart do.

研究组 & 干预措施

Radial Technical

Experimental

Radial technical is the procedure for catheterization

干预措施: Radial Technical (Procedure)

Radial Technical

Experimental

Radial technical is the procedure for catheterization

干预措施: Omnipaque (Drug)

Femoral Technical

Active Comparator

Vascular Access for cardiac catheterization

干预措施: Femoral Technical (Procedure)

Femoral Technical

Active Comparator

Vascular Access for cardiac catheterization

干预措施: Omnipaque (Drug)

结局指标

主要结局

Minutes Total Procedure Time

时间窗: Assess the total duration of the procedure in minutes. Up to 15 min

The primary outcome measure in this trial, is the time in minutes spent on the realization of the entire cardiac catheterization procedure

次要结局

  • Minute of Fluoroscopic time(Assess the total duration of the procedure in minutes. Up to 5 min)

研究者

发起方
Centro Cardiológico del Caribe, Columbia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Celin Malkun

Cardiologist Interventional

Centro Cardiológico del Caribe, Columbia

研究点 (1)

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