A cohort study evaluating upper extremity dysfunction after percutaneous coronary intervention using the radial artery as access route

A cohort study evaluating upper extremity dysfunction after percutaneous coronary intervention using the radial artery as access route - Upper extremity dysfunction post radial PCI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON38780

Enrollment

490

Registered

2013-12-19

Start date

2014-01-27

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

complaints of hand upper extremity dysfunction wrist and arm

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Presenting for TransRadial Percutaneous Coronary Intervention (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

Exclusion criteria: -Currently enrolled in another study that clinically interferes with the current study and that has not passed the primary endpoint. -The presenting condition prohibits or hinders informed consent and/or baseline examinations, such as a subconscious or semiconscious state, cardiogenic shock or cardiopulmonary resuscitation. -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 studies extremities

Design outcomes

Primary

Measure	Time frame
To answer the main objective of this study the following composite endpoint will be evaluated at two weeks: • A binary score of upper extremity dysfunction. A positive score is defined as the presence of at least a >=1 point increase in either the symptom-severity score or the functional-status score of the Levine-Katz (Boston) questionnaire or at least two of the following decreased scores two weeks after TR-PCI: o >=15% decrease in the Disabilities of the Arm, Shoulder and Hand outcome measure (DASH) compared to baseline. o Increase in Visual Analogue Scale pain score (VAS) with regard to the upper extremity of >=2 points compared to baseline. o Absent signal when evaluating the radial artery using Doppler ultrasound examination. o >=10% decrease in active range of motion (AROM) goniometry of the upper extremity compared to baseline with a minimum decrease of 10o. o Strength * >=60N decrease in palmar grip strength compared to baseline. * >=12N decrease in pinch grip strength compared to baseline. * >=15% decrease in isometric strength of the following maneuvers compared to baseline: • Flexion and extension of the elbow. • Flexion and extension of the wrist. o At least one filament decrease in sensibility of the hand using Semmes-Weinstein filaments according to WEST compared to baseline. o >=1cm increase at volumetry of the hand using the Figure of eight-method to baseline. o >=1cm increase at volumetry of the forearm measured circumferentially 8cm distal of the medial epicondyle.	—

Measure

Time frame

To answer the main objective of this study the following composite endpoint will be evaluated at two weeks: • A binary score of upper extremity dysfunction. A positive score is defined as the presence of at least a >=1 point increase in either the symptom-severity score or the functional-status score of the Levine-Katz (Boston) questionnaire or at least two of the following decreased scores two weeks after TR-PCI: o >=15% decrease in the *Disabilities of the Arm, Shoulder and Hand* outcome measure (DASH) compared to baseline. o Increase in Visual Analogue Scale pain score (VAS) with regard to the upper extremity of >=2 points compared to baseline. o Absent signal when evaluating the radial artery using Doppler ultrasound examination. o >=10% decrease in active range of motion (AROM) goniometry of the upper extremity compared to baseline with a minimum decrease of 10o. o Strength * >=60N decrease in palmar grip strength compared to baseline. * >=12N decrease in pinch grip strength compared to baseline. * >=15% decrease in isometric strength of the following maneuvers compared to baseline: • Flexion and extension of the elbow. • Flexion and extension of the wrist. o At least one filament decrease in sensibility of the hand using Semmes-Weinstein filaments according to WEST compared to baseline. o >=1cm increase at volumetry of the hand using the Figure of eight-method to baseline. o >=1cm increase at volumetry of the forearm measured circumferentially 8cm distal of the medial epicondyle.

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Secondary

Measure	Time frame
Secondary endpoints can be divided in cardiac and upper extremity related endpoints. • Cardiac related secondary endpoints o Successful arterial access of the target radial artery o Percentage of cross-over from radial to femoral access o Presence of angulation, tortuosity, stenosis or spasm o Access route complications, dissection or perforation of radial, brachial or subclavian artery o Procedural success (defined as	—

Measure

Time frame

Secondary endpoints can be divided in cardiac and upper extremity related endpoints. • Cardiac related secondary endpoints o Successful arterial access of the target radial artery o Percentage of cross-over from radial to femoral access o Presence of angulation, tortuosity, stenosis or spasm o Access route complications, dissection or perforation of radial, brachial or subclavian artery o Procedural success (defined as

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Countries

Netherlands

Outcome results