Clinical trial NCT01984411: Comparison of Vascular Access for Radial and Femoral Completion of Diagnostic Cardiac Catheterization
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ischemic Heart Diseases
Lead sponsor: Centro Cardiológico del Caribe, Columbia
Sponsor class: OTHER
First posted: 2013-11-14
Enrollment: 220
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Minutes Total Procedure Time
timeFrame: Assess the total duration of the procedure in minutes. Up to 15 min
Secondary outcomes:
measure: Minute of Fluoroscopic time
timeFrame: Assess the total duration of the procedure in minutes. Up to 5 min
Other outcomes:
measure: Complications
timeFrame: 8 days
Locations:
city: Barranquilla
country: Colombia
facility: Clinica General del Norte
state: Atlco
Study officials:
affiliation: Centro Cardiológico del Caribe, Columbia
name: Celin Malkun, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Universidad del Norte, Barranquilla, Colombia
name: Jorge Luis Acosta, MD, MSc
role: STUDY_DIRECTOR
References: