Clinical trial NCT02204423: Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Extremity Dysfunction
Keywords: Upper extremity dysfunction
Trans-Radial Percutaneous Coronary Interventions
Lead sponsor: Albert Schweitzer Hospital
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: A binary score of upper extremity dysfunction
timeFrame: 2 weeks
Secondary outcomes:
measure: Successful arterial access
timeFrame: During procedure
measure: Cross-over
timeFrame: During procedure
measure: Anomaly
timeFrame: During procedure
measure: Access route complications
timeFrame: 6 months
measure: Procedural success
timeFrame: During procedure
measure: Catheter performance
timeFrame: During procedure
measure: Procedure time
timeFrame: During procedure
measure: Radiation
timeFrame: During procedure
measure: MACCE
timeFrame: 6 months
measure: Bleeding
timeFrame: 6 months
measure: DASH
timeFrame: 6 months
measure: VAS
timeFrame: 6 months
measure: Occlusion
timeFrame: 6 months
measure: AROM
timeFrame: 6 months
measure: Strength
timeFrame: 6 months
measure: Sensibility
timeFrame: 6 months
measure: Volumetry of the hand
timeFrame: 6 months
measure: Volumetry of the forearm
timeFrame: 6 months
measure: Levine-Katz (Boston) questionnaire
timeFrame: 6 months
Other outcomes:
measure: Hand centre
timeFrame: After reaching primary endpoint
Locations:
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
state: Zuid-Holland
Study officials:
References: