search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Upper extremity dysfunction after dotter procedures via the wrist


- candidate number17677
- NTR NumberNTR4659
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR6-mei-2014
- Secondary IDsNL45613.101.13 METC
- Public TitleUpper extremity dysfunction after dotter procedures via the wrist
- Scientific TitleUpper Extremity Dysfunction Post Radial Percutaneous Coronary Interventions
- ACRONYMARCUS
- hypothesisApproximately 20% of the patients will experience complications or upper extremity dysfunction after PCI
- Healt Condition(s) or Problem(s) studiedPCI, Percutaneous Coronary Intervention (PCI), Upper limb dysfunctions
- 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 27-jan-2014
- planned closingdate1-jan-2015
- Target number of participants490
- InterventionsAll patients will, after baseline examinations be treated with the intent of using the radial artery for access.
- Primary outcomeThe main study parameter is a binary score of upper extremity dysfunction after two weeks as compared to baseline.
- Secondary outcomeThe secondary study parameters will be divided in cardiac and upper extremity related endpoints and will be used to answer the secondary objectives.
- TimepointsAfter intervention patients will undergo follow-up after 24 hours, two weeks, one and six months.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDrs. A.G.M. Koopman
- CONTACT for SCIENTIFIC QUERIESDrs. A.G.M. Koopman
- Sponsor/Initiator Carplast Fund
- Funding
(Source(s) of Monetary or Material Support)
Carplast Fund - Albert Schweitzer Ziekenhuis
- Publications-
- Brief summaryTransradial percutaneous coronary intervention is rapidly becoming the gold standard especially in primary PCI,with increased use of antithrombotic agents, where most benefit of the radial approach can be expected such as reduced major bleeding and mortality. However there is very limited research available looking at the consequences of transradial 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.
- Main changes (audit trail)
- RECORD6-mei-2014 - 15-aug-2014


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl