AzTrials
AzTrials

Upper Extremity DysfunctionNCT02204423

Upper Extremity Dysfunction Post Radial Percutaneous Coronary Intervention

A study testing Trans-Radial Percutaneous Coronary Intervention (TR-PCI) in people with Upper Extremity Dysfunction, run by Albert Schweitzer Hospital at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Upper Extremity Dysfunction
What is being tested?
Trans-Radial Percutaneous Coronary Intervention (TR-PCI)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteNetherlands
Study dates
Feb 2014to Nov 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

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

Netherlands1 site, 1 recruiting

  • Albert Schweitzer Hospital

    Dordrecht, South Holland, 3318 AT

    Roos Koopman, MD, +31-78-6550594, a.g.m.koopman@asz.nl

    Sander IJsselmuiden, MD, PHD, +31-78-6542039, s.ijsselmuiden@asz.nl

    Recruiting

Other trials in Netherlands

About this study

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

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.

Being tested
Trans-Radial Percutaneous Coronary Intervention (TR-PCI)
Keywords
Upper extremity dysfunction, Trans-Radial Percutaneous Coronary Interventions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Dotter-Procedure

Study groups in NCT02204423
Study groupRoleWhat they receive
Trans-Radial PCIExperimentalNot described
Receives: Procedure: Trans-Radial Percutaneous Coronary Intervention (TR-PCI)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 2 weeks

Secondary outcomes (19)

  1. 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.

    Measured: During procedure

  2. Cross-over

    Percentage of cross-over from radial to femoral access

    Measured: During procedure

  3. 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

    Measured: During procedure

  4. Access route complications

    Access route complications, dissection or perforation of radial, brachial or subclavian artery, as evidenced by angiography or computed tomography

    Measured: 6 months

  5. Procedural success

    Procedural success (defined as <30% residual stenosis at the end of the procedure)

    Measured: During procedure

  6. Catheter performance

    Overall catheter performance ranging from 0 (very bad) - 5 (very good)

    Measured: During procedure

  7. Procedure time

    Procedure time in minutes, from guide catheter insertion to withdrawal

    Measured: During procedure

  8. Radiation

    Radiation time and dose, in minutes and mGy

    Measured: During procedure

  9. 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)

    Measured: 6 months

  10. Bleeding

    Bleeding events (according to Academic Research Consortium definitions) at procedure and at each consecutive follow-up

    Measured: 6 months

  11. DASH

    "Disabilities of the Arm, Shoulder and Hand" (DASH) outcome measured at two weeks, one and six months

    Measured: 6 months

  12. VAS

    Visual Analogue Scale pain score (VAS) with regard to the upper extremity at one day, two weeks, one and six months.

    Measured: 6 months

  13. 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

    Measured: 6 months

  14. AROM

    Active Range Of Motion (AROM) goniometry values in degrees of the upper extremity at two weeks, one and six months.

    Measured: 6 months

  15. Strength

    • 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

    Measured: 6 months

  16. Sensibility

    Sensibility of the hand using Semmes-Weinstein filaments according to WEST at two weeks, one and six months.

    Measured: 6 months

  17. 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.

    Measured: 6 months

  18. Volumetry of the forearm

    Volumetry of the forearm in centimetres at one day, two weeks, one and six months.

    Measured: 6 months

  19. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Jul 2014 (estimated)
  2. Study startFeb 2014
  3. Primary completionMay 2015 (estimated)
  4. Study completionNov 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02204423
Sponsor's protocol ID
NL45613.101.13
Status last verified
Jul 2014
First submitted
16 Jun 2014
Last updated
30 Jul 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Trans-Radial Percutaneous Coronary Intervention (TR-PCI) in people with Upper Extremity Dysfunction, run by Albert Schweitzer Hospital at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sander IJsselmuiden, MD, PHD (+31-78-6542039, s.ijsselmuiden@asz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

A binary score of upper extremity dysfunction (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02204423.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in