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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Trans-Radial PCI | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trans-Radial Percutaneous Coronary Intervention (TR-PCI) | Procedure |
|
|
| 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:
| 2 weeks |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Hand centre | o If the primary endpoint has been reached:
| After reaching primary endpoint |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sander IJsselmuiden, MD, PHD | Contact | +31-78-6542039 | s.ijsselmuiden@asz.nl | |
| Roos Koopman, MD | Contact | +31-78-6550594 | A.g.m.koopman@asz.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albert Schweitzer Hospital | Recruiting | Dordrecht | South Holland | 3318 AT | Netherlands |
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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:
| 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:
| 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 |