Comparison of Vascular Access for Radial and Femoral Completion of Diagnostic Cardiac Catheterization
NCT ID: NCT01984411
Last Updated: 2013-11-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2013-01-31
2013-08-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radial Technical
Radial technical is the procedure for catheterization
Radial Technical
Vascular Access for cardiac catheterization
Omnipaque
Femoral Technical
Vascular Access for cardiac catheterization
Femoral Technical
Vascular Access for cardiac catheterization
Omnipaque
Interventions
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Radial Technical
Vascular Access for cardiac catheterization
Femoral Technical
Vascular Access for cardiac catheterization
Omnipaque
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
90 Years
ALL
No
Sponsors
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Centro Cardiológico del Caribe, Columbia
OTHER
Responsible Party
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Celin Malkun
Cardiologist Interventional
Principal Investigators
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Celin Malkun, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Centro Cardiológico del Caribe, Columbia
Jorge Luis Acosta, MD, MSc
Role: STUDY_DIRECTOR
Universidad del Norte, Barranquilla, Colombia
Locations
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Clinica General del Norte
Barranquilla, Atlco, Colombia
Countries
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Other Identifiers
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CCCColumbia
Identifier Type: -
Identifier Source: org_study_id