Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention

Albert Schweitzer Hospital

Status

Unknown

Conditions

Upper Extremity Dysfunction

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT02204423

NL45613.101.13

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.