Ischemic Heart Diseases Clinical Trial
— COMPACTOfficial 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
| Verified date | November 2013 |
| Source | Centro Cardiológico del Caribe, Columbia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Colombia: Ethics Committee |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 220 |
| Est. completion date | August 2013 |
| Est. primary completion date | January 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 90 Years |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Colombia | Clinica General del Norte | Barranquilla | Atlco |
| Lead Sponsor | Collaborator |
|---|---|
| Centro Cardiológico del Caribe, Columbia |
Colombia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Complications | Vascular and Clinical complications | 8 days | No |
| Primary | Minutes Total Procedure Time | The primary outcome measure in this trial, is the time in minutes spent on the realization of the entire cardiac catheterization procedure | Assess the total duration of the procedure in minutes. Up to 15 min | No |
| Secondary | Minute of Fluoroscopic time | This secindary outcome is the time in minutes spent during fluoroscopy | Assess the total duration of the procedure in minutes. Up to 5 min | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01617850 -
Efficacy of Physical Exercise in Cardiac Rehabilitation
|
N/A |