A cohort study evaluating upper extremity function after slender transradial percutaneous coronary interventio

Completed

Conditions: complaints of hand
wrist and arm
upper extremity dysfunction
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Registration Number: NL-OMON50481

Lead Sponsor: Amphia Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

- Presenting for elective slender TRPCI using *5F catheters and a stent on the
wire or RX DES Stent at one of the study centres
- The radial artery can be palpated, and Doppler ultrasound examination of the
radial artery shows non-occlusive flow.

Exclusion Criteria

- Currently enrolled in another study that clinically interferes with the
current study and that has not passed the primary endpoint.
- The clinical condition prohibits or hinders informed consent and/or baseline
examinations. E.g. cardiogenic shock and cardiopulmonary resuscitation or
subconscious and semiconscious state,
- Co-morbid condition(s) that could limit the subject*s ability to participate
in the study or to comply with follow-up requirements, or impact the scientific
integrity of the study, e.g. loss of voluntary motor control of the studied
extremities.
- Previous attempts of TRA (transradial approach) were unsuccessful.

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is a binary score of upper extremity dysfunction after<br /><br>two weeks as compared to baseline. A positive score is defined as at least two<br /><br>of the following scores, two weeks after TR-PCI, measured individual for both<br /><br>sides:<br /><br>* 2 points increase in Numeric Rating Scale for pain with regard to the upper<br /><br>extremity.<br /><br> Absent signal when evaluating the radial artery using Doppler ultrasound.<br /><br>* Strength:<br /><br>o 20% decrease in palmar grip strength compared to baseline.<br /><br>o 20% decrease in pinch grip strength compared to baseline.<br /><br>* At least 2 filaments decrease in sensibility of the hand using<br /><br>Semmes-Weinstein filaments according to WEST.<br /><br>* 7% increase of the circumference of the hand, using the Figure of<br /><br>eight-method.<br /><br> *7% increase at of the circumference of the forearm, measured at 8<br /><br>centimetres distally from the medial epicondyle.2</p><br>

Secondary Outcome Measures