Skip to main content
OpenTrials
Completed

NCT Number: NCT01984411

Comparison of Vascular Access for Radial and Femoral Completion of Diagnostic Cardiac Catheterization

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica General del Norte

Barranquilla, Atlco, NT, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Radial Technical

Procedure

Vascular Access for cardiac catheterization

Femoral Technical

Procedure

Vascular Access for cardiac catheterization

Omnipaque

Drug

Other names: Iohexol

Primary outcomes

  1. Minutes Total Procedure Time

    Time frame: 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

Secondary outcomes

  1. Minute of Fluoroscopic time

    Time frame: Assess the total duration of the procedure in minutes. Up to 5 min

    This secindary outcome is the time in minutes spent during fluoroscopy

Other outcomes

  1. Complications

    Time frame: 8 days

    Vascular and Clinical complications

Sponsors and collaborators

Lead sponsor

Centro Cardiológico del Caribe, Columbia

Other

Registry information

Official study title

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

Acronym: COMPACT

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Nov 14, 2013
Registry last updated
Nov 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.