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Completed

NCT Number: NCT02697526

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Terumo

Other

Tensoplast

Other

Primary outcomes

  1. Determination of radial artery occlusion at baseline (before catheterization)

    Time frame: 1 day

    Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods

  2. Determination of radial artery occlusion after catheterization

    Time frame: 1 week

    Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods

  3. Determination of radial artery occlusion after catheterization

    Time frame: 3 month

    Determination of radial artery occlusion at baseline (before catheterization), 1 week and 3 month after angiography/angioplasty in both compressive methods

Secondary outcomes

  1. Anatomic differences in radial and ulnar diameters

    Time frame: 3 month

    Anatomic differences in arterial lumen of radial and ulnar arteries (diameter)

  2. Differences in radial and ulnar blood flow between compression methods

    Time frame: 3 month

    Differences in radial and ulnar blood flow as a consequence of radial occlusion

  3. Differences in functional status at follow between compression groups

    Time frame: 1 day

    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.

  4. Differences in functional status at follow between compression groups

    Time frame: 1 week

    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.

  5. Differences in functional status at follow between compression groups

    Time frame: 3 month

    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.

  6. Differences in functional status between occluded radial cohort and patent radial cohort

    Time frame: 1 day

    Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.

  7. Differences in functional status between occluded radial cohort and patent radial cohort

    Time frame: 1 week

    Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.

  8. Differences in functional status between occluded radial cohort and patent radial cohort

    Time frame: 3 month

    Differences in hand mobility at baseline, 1 week and 3 month in response to radial occlusion.

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

Influence of the Compression Method After Transradial Catheterization in Radial Artery

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Mar 3, 2016
Registry last updated
Mar 3, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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