Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention

NCT02204423 | Unknown DMC

• 1 other identifier: NL45613.101.13
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Upper Extremity Dysfunction

Keywords

Upper extremity dysfunction; Trans-Radial Percutaneous Coronary Interventions

Outcome Measures

Primary Outcomes (1)

• 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: * ≥15% decrease in the DASH-outcome measure. * Increase in VAS pain score with regard to the upper extremity of ≥2 points * Absent signal of the radial artery using Doppler * 10% decrease in goniometry of the upper extremity, with a minimum decrease of 10 degree Strength * 60N decrease in palmar grip strength * 12N decrease in pinch grip strength * 15% decrease in isometric strength of the following manoeuvres: * Flexion and extension of the elbow and/or wrist * Sensibility loss of ≥1 filament of the hand using Semmes-Weinstein filaments according to WEST * 1cm increase at volumetry of the hand, using the Figure of 8-method * 1cm increase at volumetry of the forearm, measured circumferentially 8 cm distal of the medial epicondyle * Compartment syndrome

  2 weeks

Secondary Outcomes (19)

• Successful arterial access

  During procedure

• Cross-over

  During procedure

• Anomaly

  During procedure

• Access route complications

  6 months

• Procedural success

  During procedure

Other Outcomes (1)

• Hand centre

  After reaching primary endpoint

Study Arms (1)

Trans-Radial PCI

EXPERIMENTAL

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

Interventions

Trans-Radial Percutaneous Coronary Intervention (TR-PCI) PROCEDURE

Also known as: Dotter-Procedure

Trans-Radial PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Albert Schweitzer Hospital: lead

Study Sites (1)

Albert Schweitzer Hospital

Dordrecht, South Holland, 3318 AT, Netherlands

RECRUITING

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 16, 2014
• First Posted: July 30, 2014
• Study Start: February 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: November 1, 2015
• Last Updated: July 30, 2014

Record last verified: 2014-07

Locations

NL (1)