Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
Upper Extremity Dysfunction Post Radial PCI: A Cohort Study Evaluating Upper Extremity Dysfunction After Percutaneous Coronary Intervention Using the Radial Artery as Access Route

Conditions
-----------------
Upper Extremity Dysfunction

Intervention / Treatment
-----------------
* Procedure: Trans-Radial Percutaneous Coronary Intervention (TR-PCI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Presenting for TR-PCI at the study centre. 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 this 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Trans-Radial PCI<br> | Procedure: Trans-Radial Percutaneous Coronary Intervention (TR-PCI)<br> <br> * Other names: Dotter-Procedure;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A 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 | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | During procedure | 
| Cross-over | Percentage of cross-over from radial to femoral access | 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 | During procedure | 
| Access route complications | Access route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography | 6 months | 
| Procedural success | Procedural success (defined as <30% residual stenosis at the end of the procedure) | During procedure | 
| Catheter performance | Overall catheter performance ranging from 0 (very bad) - 5 (very good) | During procedure | 
| Procedure time | Procedure time in minutes, from guide catheter insertion to withdrawal | During procedure | 
| Radiation | Radiation time and dose, in minutes and mGy | 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) | 6 months | 
| Bleeding | Bleeding events (according to Academic Research Consortium definitions) at procedure and at each consecutive follow-up | 6 months | 
| DASH | Disabilities of the Arm, Shoulder and Hand (DASH) outcome measured at two weeks, one and six months | 6 months | 
| VAS | Visual Analogue Scale pain score (VAS) with regard to the upper extremity at one day, two weeks, one and six months. | 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 | 6 months | 
| AROM | Active Range Of Motion (AROM) goniometry values in degrees of the upper extremity at two weeks, one and six months. | 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 | 6 months | 
| Sensibility | Sensibility of the hand using Semmes-Weinstein filaments according to WEST at two weeks, one and six months. | 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. | 6 months | 
| Volumetry of the forearm | Volumetry of the forearm in centimetres at one day, two weeks, one and six months. | 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 | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Upper extremity dysfunction, Trans-Radial Percutaneous Coronary Interventions