Reperfusion Injury after ischemic Stroke Study (RISKS): single-centre (Florence, Italy), prospective observational protocol study
Articolo
Data di Pubblicazione:
2018
Citazione:
Reperfusion Injury after ischemic Stroke Study (RISKS): single-centre (Florence, Italy), prospective observational protocol study / B. Piccardi, F. Arba, M. Nesi, V. Palumbo, P. Nencini, B. Giusti, A. Sereni, D. Gadda, M. Moretti, E. Fainardi, S. Mangiafico, G. Pracucci, S. Nannoni, F. Galmozzi, A. Fanelli, P. Pezzati, S. Vanni, S. Grifoni, C. Sarti, M. Lamassa, A. Poggesi, F. Pescini, L. Pantoni, A.M. Gori, D. Inzitari. - In: BMJ OPEN. - ISSN 2044-6055. - 8:5(2018 May 24). [10.1136/bmjopen-2017-021183]
Abstract:
Introduction Treatments aiming at reperfusion of the
acutely ischaemic brain tissue may result futile or even
detrimental because of the so-called reperfusion injury.
The processes contributing to reperfusion injury involve a
number of factors, ranging from blood–brain barrier (BBB)
disruption to circulating biomarkers. Our aim is to evaluate
the relative effect of imaging and circulating biomarkers in
relation to reperfusion injury.
Methods and analysis Observational hospital-based
study that will include 140 patients who had ischaemic
stroke, treated with systemic thrombolysis, endovascular
treatment or both. BBB disruption will be assessed with
CT perfusion (CTP) before treatment, and levels of a large
panel of biomarkers will be measured before intervention
and after 24 hours. Relevant outcomes will include: (1)
reperfusion injury, defined as radiologically relevant
haemorrhagic transformation at 24 hours and (2) clinical
status 3 months after the index stroke. We will investigate
the separate and combined effect of pretreatment BBB
disruption and circulating biomarkers on reperfusion injury
and clinical status at 3 months. Study protocol is registered
at http://www. clinicaltrials. gov ( ClinicalTrials. gov ID:
NCT03041753).
Ethics and dissemination The study protocol has been
approved by ethics committee of the Azienda Ospedaliero
Universitaria Careggi (Università degli Studi di Firenze).
Informed consent is obtained by each patient at time of
enrolment or deferred when the participant lacks the
capacity to provide consent during the acute phase.
Researchers interested in testing hypotheses with the
data are encouraged to contact the corresponding author.
Results from the study will be disseminated at national
and international conferences and in medical thesis.
Trial registration number NCT03041753.
Tipologia IRIS:
01 - Articolo su periodico
Keywords:
blood brain barrier; endovascular treatment; reperfusion injury; stroke; thrombolysis
Elenco autori:
B. Piccardi, F. Arba, M. Nesi, V. Palumbo, P. Nencini, B. Giusti, A. Sereni, D. Gadda, M. Moretti, E. Fainardi, S. Mangiafico, G. Pracucci, S. Nannoni, F. Galmozzi, A. Fanelli, P. Pezzati, S. Vanni, S. Grifoni, C. Sarti, M. Lamassa, A. Poggesi, F. Pescini, L. Pantoni, A.M. Gori, D. Inzitari
Link alla scheda completa:
Link al Full Text: