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 the following:• To provide insight at the…
ID
Source
Brief title
Condition
- Coronary artery disorders
- Joint disorders
- Peripheral neuropathies
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
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 <30% residual stenosis)
o Procedure time
o Radiation time and dose
o Major adverse cardiac events (MACE) at procedure.
o Bleeding events at procedure and at each follow-up
o MACE at each follow-up
• Upper extremity related secondary endpoints
o Symptom-severity score and the functional-status score of the Levine-Katz
(Boston) questionnaire at two weeks, one and six months
o DASH outcome measure at two weeks, one and six months.
o VAS-score with regard to the upper extremity at one day, two weeks, one and
six months.
o 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.
o AROM goniometry values of the upper extremity at two weeks, one and six
months.
o Strength at two weeks, one and six months:
* Palmar grip strength
* Pinch grip strength
* Isometric strength of the following maneuvers:
• Flexion and extension of the elbow
• Flexion and extension of the wrist
o Sensibility of the hand using Semmes-Weinstein filaments according to WEST at
two weeks, one and six months.
o Volumetry of the hand using the Figure of eight-method extremity at one day,
two weeks, one and six months.
o Volumetry of the forearm at one day, two weeks, one and six months.
o If the primary endpoint has been reached:
* Diagnostic procedures
* Diagnosis
* Performed treatment
* Upper extremity related absence of work in days
Background summary
The radial artery as access for percutaneous coronary interventions (PCI) was
first considered as such in 1992 by Kiemeneij et al and is rapidly becoming the
gold standard especially in primary PCI during which multiple antithrombotic
agents are used. The main rationale for this conversion from femoral access to
radial access is the significantly decreased mortality when compared to the
femoral route even considering the slightly increased learning curve.
However despite these positive findings regarding radial artery access several
anecdotal or methodological poor articles exist in the literature regarding
non-lethal complications. Such as endothelial denudation and hematomas, caused
by spasm or perforation. These can result in extensive oedema or even
compartment syndrome possibly resulting in permanent neurovascular damage of
the upper extremity. Other described complications of TR-PCI are radial artery
occlusion possibly resulting in hand ischemia, arterio venous fistula,
pseudoaneurysms, chronic pain or CRPS. These less frequent but possibly
debilitating complications are reported in very low incidences in larger
studies or only in case reports. The possible subsequent dysfunction of the
target upper extremity post TR-PCI has never been properly evaluated.
The proposed study has the intention to provide more insight in these access
route complications, the risk factors for developing these complications and
the influence of transradial access on upper extremity function after TR-PCI.
More research on these radial artery access route complications is necessary in
creating a complete profile of complications of the increasingly popular and
very successful transradial intervention especially focusing on upper extremity
and hand function.
Study objective
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 the following:
• To provide insight at the consequences of this morbidity regarding functional
status.
• To identify factors that influence the occurrence of upper extremity
complications post TR-PCI.
• To identify subjects who might benefit from early referral to a dedicated
*hand centre*.
• To provide insight at the financial consequences of these upper extremity
complications both by increased health consumption as well as decreased labour
productivity.
• To generate hypotheses for further clinical research with regard to upper
extremity dysfunction after TR-PCI.
Study design
Single centre prospective cohort study without control group of 500 subjects.
The primary endpoint is determined after two weeks and a total follow-up
duration of six months is planned.
Study burden and risks
- Time consumption, completing questionnaires, aditional physicla examination
en doppler ultrasound
- Benefit of early detection of possible complications due to intensive
follow-up
Albert Schweitzerplaats 25
Dordrecht 3318 AT
NL
Albert Schweitzerplaats 25
Dordrecht 3318 AT
NL
Listed location countries
Age
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
-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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45613.101.13 |
| Other | volgt |
| OMON | NL-OMON23742 |