Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention

Upper Extremity Dysfunction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02204423
• Other study ID #: NL45613.101.13
• Status: Recruiting
• Phase: N/A
• First received: June 16, 2014
• Last updated: July 29, 2014
• Start date: February 2014
• Est. completion date: November 2015

Study information

• Verified date: July 2014
• Source: Albert Schweitzer Hospital
• Contact: Sander IJsselmuiden, MD, PHD
• Phone: +31-78-6542039
• Email: s.ijsselmuiden[@]asz.nl
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: November 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Upper Extremity Dysfunction

Intervention

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

Locations

Country	Name	City	State
Netherlands	Albert Schweitzer Hospital	Dordrecht	Zuid-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Albert Schweitzer Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	Cross-over	Percentage of cross-over from radial to femoral access	During procedure	No
Secondary	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	No
Secondary	Access route complications	Access route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography	6 months	No
Secondary	Procedural success	Procedural success (defined as <30% residual stenosis at the end of the procedure)	During procedure	No
Secondary	Catheter performance	Overall catheter performance ranging from 0 (very bad) - 5 (very good)	During procedure	No
Secondary	Procedure time	Procedure time in minutes, from guide catheter insertion to withdrawal	During procedure	No
Secondary	Radiation	Radiation time and dose, in minutes and mGy	During procedure	No
Secondary	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	No
Secondary	Bleeding	Bleeding events (according to Academic Research Consortium definitions) at procedure and at each consecutive follow-up	6 months	No
Secondary	DASH	"Disabilities of the Arm, Shoulder and Hand" (DASH) outcome measured at two weeks, one and six months	6 months	No
Secondary	VAS	Visual Analogue Scale pain score (VAS) with regard to the upper extremity at one day, two weeks, one and six months.	6 months	No
Secondary	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	No
Secondary	AROM	Active Range Of Motion (AROM) goniometry values in degrees of the upper extremity at two weeks, one and six months.	6 months	No
Secondary	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 elbow; Flexion and extension of the wrist	6 months	No
Secondary	Sensibility	Sensibility of the hand using Semmes-Weinstein filaments according to WEST at two weeks, one and six months.	6 months	No
Secondary	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	No
Secondary	Volumetry of the forearm	Volumetry of the forearm in centimetres at one day, two weeks, one and six months.	6 months	No
Secondary	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	No