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)


Detection of myocardial damage after device implantation


- candidate number18309
- NTR NumberNTR4676
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jul-2014
- Secondary IDsMETC  Erasmus MC
- Public TitleDetection of myocardial damage after device implantation
- Scientific TitleThe value of high-sensitive troponin T in detection of acute myocardial damage after device implantation
- ACRONYMISOTONE
- hypothesisWithin 24hours after implantation, high-sensitive troponin T is elevated as a result of myocardial damge
- Healt Condition(s) or Problem(s) studiedImplantable cardiac device (ICD), Myocardial ischemia, Troponin
- Inclusion criteriaAdults scheduled for pacemaker of ICD implantation
- Exclusion criteriaMental disability
Acute myocardial infarction <30 days before implantation
Congenital heart defects
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-sep-2014
- planned closingdate31-aug-2016
- Target number of participants262
- InterventionsIn each patient, 4 blood samples will be taken
- Primary outcomeThe value of high-sensitive troponin T after pacemaker or ICD implantation.
The study endpoint is reached after a follow-up period of 6 months unless an acute myocardial infarction occurs before that moment
- Secondary outcomePatient and procedural characteristics that might influence the outcome of the main study parameter
- TimepointsBetween 12 and 24 hours prior to device implantation, one blood sample will be taken.
In addition, 3, 6 and 24 hours after device implantation new blood samples will be obtained
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMrs. Dr. N.M.S. Groot, de
- CONTACT for SCIENTIFIC QUERIESMrs. Dr. N.M.S. Groot, de
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summaryTo examine the range of values of hsTnT between patients after implantation of a device ((bi-ventricular) ICD or pacemaker (PM)) in order to define new hsTnT reference values.
- Main changes (audit trail)
- RECORD8-jul-2014 - 6-aug-2014


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