Differences in Radial Artery Occlusion From Two Different Compressive Methods Used in Patients in Order to Achieve Homeostasis After Transradial Catheterization and Their Repercussion in Artery Functionality and Hand Mobility

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to determine differences on radial artery occlusion from two compressive methods used after transradial catheterization and its functional impact on hand mobility.

Detailed Description
-----------------
Changes in Allen's test and pulse oximetry will be evaluated at baseline, 1 week and 3 month of catheterization in both groups of patients in order to check the functionality of the communications between the ulnar and radial arteries. The repercussion of each compressive method on radial occlusion and artery revascularization will be assessed by eco-Doppler at any time. Changes in diameter of arterial lumen of radial and ulnar arteries as a consequence of radial occlusion will be done simultaneously of blood flow Doppler measurements. The possible impact of radial occlusion on hand mobility will be done using a dynamometer designed to evaluate strength (Endurance test) and muscular claudication (Rapid exchange test).

Official Title
-----------------
Influence of the Compression Method After Transradial Catheterization in Radial Artery

Conditions
-----------------
Transradial Catheterization

Intervention / Treatment
-----------------
* Other: Terumo
* Other: Tensoplast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in whom at least the diagnostic catheterization has been done successfully by the radial artery route. Patients with a negative Allen's Clinical test showing hyperemia before 9 seconds after pressure release over the ulnar artery pulse. Patients showing a Barbeau pattern A,B or C with the pulsioximetric test after releasing pressure over the ulnar artery pulse. Patients that will be able to do the follow up visits at 1 week and 3 month. Signature of informed consent Exclusion Criteria: Patients in that neither the diagnostic or therapeutic procedure has successfully done via the radial artery route. Patients with a positive Allen's test (no hyperemia) after pressure and release over the ulnar artery pulse. Patients showing a Barbeau pattern D with the pulsioximetric test after releasing pressure over the ulnar artery pulse. Inability to visit at 1 week and 3 month. Impossibility to obtain informed consent form

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Terumo<br>Patients in this arm will receive Terumo after catheterization | Other: Terumo<br> <br> |
| Other: Tensoplast<br>Patients in this arm will receive Tensoplast after catheterization | Other: Tensoplast<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of radial artery occlusion at baseline (before catheterization) | Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods | 1 day | 
| Determination of radial artery occlusion after catheterization | Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods | 1 week | 
| Determination of radial artery occlusion after catheterization | Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic differences in radial and ulnar diameters | Anatomic differences in arterial lumen of radial and ulnar arteries (diameter) | 3 month | 
| Differences in radial and ulnar blood flow between compression methods | Differences in radial and ulnar blood flow as a consequence of radial occlusion | 3 month | 
| Differences in functional status at follow between compression groups | Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis. | 1 day | 
| Differences in functional status at follow between compression groups | Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis. | 1 week | 
| Differences in functional status at follow between compression groups | Differences in hand mobility at baseline, 1 week and 3 month of catheterization as a consequence of radial occlusion in relation with the compressive method used to achieve homeostasis. | 3 month | 
| Differences in functional status between occluded radial cohort and patent radial cohort | Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion. | 1 day | 
| Differences in functional status between occluded radial cohort and patent radial cohort | Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion. | 1 week | 
| Differences in functional status between occluded radial cohort and patent radial cohort | Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion. | 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
radial artery, occlusion, functional, complications, consequences