Approximately 20% of the patients will experience complications or upper extremity dysfunction after PCI
ID
Bron
Verkorte titel
Aandoening
transradial percutaneous coronary interventions, upper extremity dysfunction
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The main study parameter is a binary score of upper extremity dysfunction after two weeks as compared to baseline.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
Approximately 20% of the patients will experience complications or upper extremity dysfunction after PCI
Onderzoeksopzet
After intervention patients will undergo follow-up after 24 hours, two weeks, one and six months.
Onderzoeksproduct en/of interventie
All patients will, after baseline examinations be treated with the intent of using the radial artery for access.
Publiek
Albert Schweitzerplaats 25
A.G.M. Koopman
Dordrecht 3318 AT
The Netherlands
+3178 655 0594
a.g.m.koopman@asz.nl
Wetenschappelijk
Albert Schweitzerplaats 25
A.G.M. Koopman
Dordrecht 3318 AT
The Netherlands
+3178 655 0594
a.g.m.koopman@asz.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
• 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
• 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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL4523 |
NTR-old | NTR4659 |
CCMO | NL45613.101.13 |
OMON | NL-OMON38780 |