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MYOcardial ischemia detection by circulating bioMARKERs: ‘ the MYOMARKER-study’


- candidate number22068
- NTR NumberNTR5210
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR1-mei-2015
- Secondary IDsTWO 14-25 NL48721.100.14
- Public TitleMYOcardial ischemia detection by circulating bioMARKERs: ‘ the MYOMARKER-study’
- Scientific TitleMYOcardial ischemia detection by circulating bioMARKERs: ‘ the MYOMARKER-study’
Examining blood chemical markers in patients in the outpatient clinic with suspected coronary artery disease: the value of extracellular vesicles and circulating cells for diagnosing myocardial ischemia
- ACRONYMMYOMARKER
- hypothesisTo analyse the diagnostic and prognostic value of plasma EV protein/miRNA and gene expression profiles of circulating cells for objectified ischemic coronary artery disease in patients with symptoms (e.g. chest pain) suggestive of coronary artery disease.
- Healt Condition(s) or Problem(s) studiedAngina Pectoris, Myocardial ischemia
- Inclusion criteria- Patients in the cardiology outpatient clinic of the Meander Medical Center Amerfoort being evaluated because of suspected ischemic coronary disease, who will undergo radionuclide myocardial perfusion imaging (rMPI), as indicated by the treating cardiologist.
- Age > 18yr
- Exclusion criteria- Patients from whom no informed consent is obtained
- Incapacitated adults: language barriers or other obstacles for full understanding of the study objectives
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 12-aug-2014
- planned closingdate12-aug-2017
- Target number of participants1265
- InterventionsNone. The study has a prospective (diagnostic and prognostic) observational design. At the day of inclusion 6 tubes of venous blood (60cc in total) will be withdrawn from the intravenous peripheral access (canula) that is already inserted due to the rMPI protocol.
- Primary outcomeParameter; Extracellular vesicle protein- and miRNA-concentration, and gene expression profiles in circulating cells.
Endpoint: Objectified ischemic coronary artery disease, determined by radionuclide myocardial perfusion imaging (Rubidium-82).
- Secondary outcomeFollow-up: all-cause mortality, cardiovascular death, non-fatal MI, coronary revascularisation, stroke, and peripheral vascular interventions.
- Timepoints- Blood collection (60cc) at the day of inclusion.
- Follow-up assessment at 1 month, 1 year and 2 years after inclusion.
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Ingrid E.M. Bank
- CONTACT for SCIENTIFIC QUERIES Ingrid E.M. Bank
- Sponsor/Initiator Meander Medical Center Amersfoort
- Funding
(Source(s) of Monetary or Material Support)
Meander Medical Center Amersfoort, University Medical Center Utrecht (UMCU)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD1-mei-2015 - 17-okt-2015


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