Trans-Radial Percutaneous Coronary Intervention (TR-PCI) is rapidly becoming the gold standard. This is especially the case in primary Percutaneous Coronary Interventions (PCI), where most benefits of the radial approach, such as reduced major bleeding and mortality, can be expected. However there is very limited research available looking at the consequences of trans-radial access for upper extremity function. The main objective of this study is to provide insight in the morbidity with regards to the upper extremity surrounding the radial access route in percutaneous coronary interventions. Secondary objectives are to provide insight in the consequences for functional status, factors influencing and financial costs of this morbidity, to identify subject who might benefit from early referral and treatment of this morbidity and to generate hypotheses for further clinical research into this matter. The investigators hypothesis is that approximately 20% of the population will experience upper extremity dysfunction after TR-PCI.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
500
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands
RECRUITINGA binary score of upper extremity dysfunction
A positive score is defined as the presence of at least a ≥1 point increase in the Levine-Katz (Boston) questionnaire; or at least 2 of the following decreased scores compared to baseline, 2 weeks after TR-PCI: * ≥15% decrease in the DASH-outcome measure. * Increase in VAS pain score with regard to the upper extremity of ≥2 points * Absent signal of the radial artery using Doppler * 10% decrease in goniometry of the upper extremity, with a minimum decrease of 10 degree Strength * 60N decrease in palmar grip strength * 12N decrease in pinch grip strength * 15% decrease in isometric strength of the following manoeuvres: * Flexion and extension of the elbow and/or wrist * Sensibility loss of ≥1 filament of the hand using Semmes-Weinstein filaments according to WEST * 1cm increase at volumetry of the hand, using the Figure of 8-method * 1cm increase at volumetry of the forearm, measured circumferentially 8 cm distal of the medial epicondyle * Compartment syndrome
Time frame: 2 weeks
Successful arterial access
Successful arterial access of the target radial artery, defined as the ability to successfully advance a guiding catheter and position it in the coronary ostium.
Time frame: During procedure
Cross-over
Percentage of cross-over from radial to femoral access
Time frame: During procedure
Anomaly
Presence of branching anomaly (high radial artery take-off), tortuosity (none, mild, moderate or severe), stenosis (not encountered or percentage of stenosis encountered) and/or spasm (none, mild, moderate or severe) of the radial artery
Time frame: During procedure
Access route complications
Access route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography
Time frame: 6 months
Procedural success
Procedural success (defined as \<30% residual stenosis at the end of the procedure)
Time frame: During procedure
Catheter performance
Overall catheter performance ranging from 0 (very bad) - 5 (very good)
Time frame: During procedure
Procedure time
Procedure time in minutes, from guide catheter insertion to withdrawal
Time frame: During procedure
Radiation
Radiation time and dose, in minutes and mGy
Time frame: During procedure
MACCE
Major adverse cardiac and cerebrovascular events (MACCE), defined as: * Myocardial infarction (MI), according to the Third Universal definition of Myocardial Infarction * Target vessel revascularisation, either by PCI or surgical * Death * Cerebrovascular accident (CVA)
Time frame: 6 months
Bleeding
Bleeding events (according to Academic Research Consortium definitions) at procedure and at each consecutive follow-up
Time frame: 6 months
DASH
"Disabilities of the Arm, Shoulder and Hand" (DASH) outcome measured at two weeks, one and six months
Time frame: 6 months
VAS
Visual Analogue Scale pain score (VAS) with regard to the upper extremity at one day, two weeks, one and six months.
Time frame: 6 months
Occlusion
Presence or absence of arterial pulse when evaluating the radial artery using Doppler ultrasound examination extremity at one day, two weeks, one and six months
Time frame: 6 months
AROM
Active Range Of Motion (AROM) goniometry values in degrees of the upper extremity at two weeks, one and six months.
Time frame: 6 months
Strength
o Strength in Newton at two weeks, one and six months: * Palmar grip strength * Pinch grip strength * Isometric strength of the following manoeuvres: * Flexion and extension of the elbow * Flexion and extension of the wrist
Time frame: 6 months
Sensibility
Sensibility of the hand using Semmes-Weinstein filaments according to WEST at two weeks, one and six months.
Time frame: 6 months
Volumetry of the hand
Volumetry of the hand in centimeters using the Figure of eight-method extremity at one day, two weeks, one and six months.
Time frame: 6 months
Volumetry of the forearm
Volumetry of the forearm in centimetres at one day, two weeks, one and six months.
Time frame: 6 months
Levine-Katz (Boston) questionnaire
Symptom-severity score and the functional-status score of the Levine-Katz (Boston) questionnaire at two weeks, one and six months
Time frame: 6 months
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