Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention

Upper Extremity Dysfunction Post Radial PCI: A Cohort Study Evaluating Upper Extremity Dysfunction After Percutaneous Coronary Intervention Using the Radial Artery as Access Route

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.

Study Overview

• Status: Unknown
• Conditions: Upper Extremity Dysfunction
• Intervention / Treatment: Procedure: Trans-Radial Percutaneous Coronary Intervention (TR-PCI)

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid-Holland
    • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
      • Recruiting
      • Albert Schweitzer Hospital
      • Principal Investigator: Sander IJsselmuiden, MD, PHD
      • Contact: Sander IJsselmuiden, MD, PHD; Phone Number: +31-78-6542039; Email: s.ijsselmuiden@asz.nl
      • Contact: Roos Koopman, MD; Phone Number: +31-78-6550594; Email: a.g.m.koopman@asz.nl
      • Sub-Investigator: Carlo Holtzer, MD, PHD
      • Sub-Investigator: Roos Koopman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Trans-Radial PCI	Procedure: Trans-Radial Percutaneous Coronary Intervention (TR-PCI); Other Names: Dotter-Procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Doppler10% decrease in goniometry of the upper extremity, with a minimum decrease of 10 degree Strength60N decrease in palmar grip strength12N decrease in pinch grip strength15% 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 WEST1cm increase at volumetry of the hand, using the Figure of 8-method1cm increase at volumetry of the forearm, measured circumferentially 8 cm distal of the medial epicondyle; Compartment syndrome	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Successful arterial access	Successful arterial access of the target radial artery, defined as the ability to successfully advance a guiding catheter and position it in the coronary ostium.	During procedure
Cross-over	Percentage of cross-over from radial to femoral access	During procedure
Anomaly	Presence of branching anomaly (high radial artery take-off), tortuosity (none, mild, moderate or severe), stenosis (not encountered or percentage of stenosis encountered) and/or spasm (none, mild, moderate or severe) of the radial artery	During procedure
Access route complications	Access route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography	6 months
Procedural success	Procedural success (defined as <30% residual stenosis at the end of the procedure)	During procedure
Catheter performance	Overall catheter performance ranging from 0 (very bad) - 5 (very good)	During procedure
Procedure time	Procedure time in minutes, from guide catheter insertion to withdrawal	During procedure
Radiation	Radiation time and dose, in minutes and mGy	During procedure
MACCE	Major adverse cardiac and cerebrovascular events (MACCE), defined as: Myocardial infarction (MI), according to the Third Universal definition of Myocardial Infarction; Target vessel revascularisation, either by PCI or surgical; Death; Cerebrovascular accident (CVA)	6 months
Bleeding	Bleeding events (according to Academic Research Consortium definitions) at procedure and at each consecutive follow-up	6 months
DASH	"Disabilities of the Arm, Shoulder and Hand" (DASH) outcome measured at two weeks, one and six months	6 months
VAS	Visual Analogue Scale pain score (VAS) with regard to the upper extremity at one day, two weeks, one and six months.	6 months
Occlusion	Presence or absence of arterial pulse when evaluating the radial artery using Doppler ultrasound examination extremity at one day, two weeks, one and six months	6 months
AROM	Active Range Of Motion (AROM) goniometry values in degrees of the upper extremity at two weeks, one and six months.	6 months
Strength	o Strength in Newton at two weeks, one and six months: Palmar grip strength; Pinch grip strength; Isometric strength of the following manoeuvres:Flexion and extension of the elbowFlexion and extension of the wrist	6 months
Sensibility	Sensibility of the hand using Semmes-Weinstein filaments according to WEST at two weeks, one and six months.	6 months
Volumetry of the hand	Volumetry of the hand in centimeters using the Figure of eight-method extremity at one day, two weeks, one and six months.	6 months
Volumetry of the forearm	Volumetry of the forearm in centimetres at one day, two weeks, one and six months.	6 months
Levine-Katz (Boston) questionnaire	Symptom-severity score and the functional-status score of the Levine-Katz (Boston) questionnaire at two weeks, one and six months	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand centre	o If the primary endpoint has been reached: Diagnostic procedures performed at the hand centre; Diagnosis of the hand centre; Performed treatment at the hand centre; Upper extremity related absence of work in days	After reaching primary endpoint

Collaborators and Investigators

• Sponsor: Albert Schweitzer Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Anticipated): May 1, 2015
• Study Completion (Anticipated): November 1, 2015

Study Registration Dates

• First Submitted: June 16, 2014
• First Submitted That Met QC Criteria: July 29, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): July 30, 2014
• Last Update Submitted That Met QC Criteria: July 29, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: Upper extremity dysfunction; Trans-Radial Percutaneous Coronary Interventions
• Additional Relevant MeSH Terms: Musculoskeletal Diseases
• Other Study ID Numbers: NL45613.101.13