No registrations found.
ID
Source
Brief title
Health condition
transradial percutaneous coronary interventions, upper extremity dysfunction
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is a binary score of upper extremity dysfunction after two weeks as compared to baseline.
Secondary outcome
The secondary study parameters will be divided in cardiac and upper extremity related endpoints and will be used to answer the secondary objectives.
Background summary
Transradial percutaneous coronary intervention is rapidly becoming the gold standard especially in primary PCI,with increased use of antithrombotic agents, where most benefit of the radial approach can be expected such as reduced major bleeding and mortality. However there is very limited research available looking at the consequences of transradial 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.
Study objective
Approximately 20% of the patients will experience complications or upper extremity dysfunction after PCI
Study design
After intervention patients will undergo follow-up after 24 hours, two weeks, one and six months.
Intervention
All patients will, after baseline examinations be treated with the intent of using the radial artery for access.
Albert Schweitzerplaats 25
A.G.M. Koopman
Dordrecht 3318 AT
The Netherlands
+3178 655 0594
a.g.m.koopman@asz.nl
Albert Schweitzerplaats 25
A.G.M. Koopman
Dordrecht 3318 AT
The Netherlands
+3178 655 0594
a.g.m.koopman@asz.nl
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4523 |
| NTR-old | NTR4659 |
| CCMO | NL45613.101.13 |
| OMON | NL-OMON38780 |