IMPROVE Handstudie

Recruiting

Conditions: Percutaneous coronary interventionUpper extremity dysfunctionSlender PCIRadial artery

Registration Number: NL-OMON19902

Lead Sponsor: Investigator initiated:dr. A.J.J. IJsselmuiden, Interventional Cardiologist

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Presenting for elective slender TRPCI using 5F catheters and slender PCI 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 scientiÍic 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 non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The main study parameter is a binary score of upper extremity dysfunction after two weeks as compared to baseline. A positive score is defined as 1 point increase in at least two of the following scores, measured individual for both sides, two weeks after TR-PCl:<br>. At least 2 points increase in Numeric Rating Scale for pain with regard to the upper extremity.<br>. Absent signal when evaluating the radial artery using Doppler ultrasound.<br>. Strength:<br> At least 20% decrease in palmar grip strength compared to baseline.<br> At least 20% decrease in pinch grip strength compared to baseline.<br>. At least two filaments decrease in sensibility of the hand using Semmes-Weinstein filaments according to WEST.<br>. At least 7% increase of the circumference of the hand, using the Figure of eight-method.<br>. At least 7% increase of the circumference of the forearm, measured at 8 centimetres distally from the medial epicondyle.

Secondary Outcome Measures