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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02697526
Other study ID # PR(AG)70/2006
Secondary ID
Status Completed
Phase N/A
First received February 23, 2016
Last updated February 26, 2016
Start date January 2007
Est. completion date May 2008

Study information

Verified date February 2016
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority Spain: Ethics Committee
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Completed
Enrollment 274
Est. completion date May 2008
Est. primary completion date May 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Other:
Terumo

Tensoplast


Locations

Country Name City State
Spain Hospital Universitari Vall d`Hebron Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

References & Publications (65)

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Kiemeneij F, Vajifdar BU, Eccleshall SC, Laarman G, Slagboom T, van der Wieken R. Measurement of radial artery spasm using an automatic pullback device. Catheter Cardiovasc Interv. 2001 Dec;54(4):437-41. — View Citation

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* Note: There are 65 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Primary 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 No
Secondary Anatomic differences in radial and ulnar diameters Anatomic differences in arterial lumen of radial and ulnar arteries (diameter) 3 month No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No
Secondary 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 No