|- candidate number||19441|
|- NTR Number||NTR4786|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-sep-2014|
|- Secondary IDs|| |
|- Public Title||Diagnostic value of distention and intima-media thickness measurement for the detection of endofibrosis and a possible role of the coagulation activation potential on the development of endofibrosis.|
|- Scientific Title||What is the diagnostic value of distention and intima-media thickness measurement for the early detection of endofibrosis and is there a link between the development of endofibrosis an the coagulation activation potential of the blood?|
|- hypothesis||Can IMT and Distension measurment of the iliacal artery determine Endofibrosis in an early stage and is there a link between the development of endofibrosis and the coagulation activation potential of the blood?|
|- Healt Condition(s) or Problem(s) studied||Coagulation, Blood coagulation, Endofibrosis|
|- Inclusion criteria||Controle population: minimal 18 years old and max 35 years old - mentally capable
Population with endofibrosis: - minimal 18 years old and maximal 35. - mentally capable - complaining of lower limb ischemia during exercise - confirmed endofibrosis by Magnetic Resonance Angiography.
|- Exclusion criteria||All population: diagnosed with an cardiovascular disease, operation on the a. iliacal communis or a. iliacal externa, BMI > 30, <18 years old, pregnancy|
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-okt-2014|
|- planned closingdate||1-feb-2015|
|- Target number of participants||70|
|- Interventions||Ultrasound of the iliacal artery|
Blood collection from the forearm (30mL)
|- Primary outcome||Determining the IMT of the common iliac artery wall. |
Determining the distension of the pelvic arterial wall.
Determine coagulation parameters
|- Secondary outcome||x|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Jelle Posthuma|
|- CONTACT for SCIENTIFIC QUERIES|| Jelle Posthuma|
|- Sponsor/Initiator ||University Maastricht (UM)|
(Source(s) of Monetary or Material Support)
|Kootstra Talent Fellowship|
|- Publications||Posthuma JJ et al. Cycling induces a hypercoagulable state through contat activation. |
|- Brief summary||Endofibrosis is an disease affecting 15-20% of the young (17-30 years old) professional cyclists and speed skaters. The disease is characterized by fibrotic tissue formation in the iliacal artery, resulting in a stenosis. As a result of this the bloodflow is reduced, resulting in unilateral ischemic symptoms.|
To date the mechanism behind this fibrotic tissue formation is still unknown. However, the development of the fibrotic tissue formation is linked to activation of Protease Activated Receptors (PARs) by active coagulation factors. It's known that activation of these receptors by active coagulation factors can affect the vessel wall composition, however data is fragmented and the underlying mechanism is not known yet. So information about this could provide new insights in these processes and it can possibly be linked to the development of endofibrosis.
Endofibrosis is irreversible, so an surgical intervention is needed to solve the problem. Endofibrosis is with the current diagnostic methods (Duplex and Magnetic Resonance Angiography) only detectable in an late phase of the disease, when the patient already experiences significant symptoms. Recently a new diagnostic method is developed, with which vessel wall changes can be detected in an earlier stage. This method is based on intimal-media thickness (IMT) en distention measurement of the vessel wall by echography.
Since recent research found a new therapeutic target to inhibit fibrotic tissue formation in an early stage, early detection of the disease plays an important role to set up an noninvasive therapy.
|- Main changes (audit trail)|
|- RECORD||11-sep-2014 - 10-okt-2014|