Ischemic Heart Diseases Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01617850 -
Efficacy of Physical Exercise in Cardiac Rehabilitation
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N/A |