CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 10 enrolled
Drug / intervention
Open heart surgeryother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01319799
NCT01319799N/ACompleted

Microembolic Signals and Cerebrospinal Fluid Markers of Neuronal Damage After Surgical Aortic Valve

Sahlgrenska University Hospital·observational·Posted Mar 22, 2011·Updated Mar 29, 2017

In Brief

An observational study evaluating Open heart surgery for Aortic Stenosis. Completed, enrolled 10 participants across 1 site.

Detailed Summary

The use of MRI have shown that the incidence of postoperative cerebral lesions due to cerebral embolization is high (1). Nonetheless the extent of postoperative neurological dysfunction is only a fraction of the actual amount of new postoperative changes detected on MRI. Transcranial Doppler (TCD) has shown the occurrence of extensive microembolic signals in intracerebral arteries during open heart procedures (2). The clinical significance of cerebral microemboli is not clear (3-5). The use of serological markers to assess cerebral injury after open cardiac surgery is difficult to interpret. The levels of markers seems to be contaminated from extracerebral sources (6). In order assess the release of markers of neuronal damage after open aortic valve surgery the investigators intend to examine the levels of S-100B, NSE and Tau in cerebrospinal fluid (CSF) by comparing the levels preoperative with the levels one day after surgery. Furthermore the investigators will determine the total amount of cerebral microembolic signals during the surgical procedure by means of TCD. The investigators will statistically test if there is any correlation between the increase in cerebrospinal fluid levels of S-100B,NSE and Tau and the cerebral embolic load.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAortic Stenosis
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 22, 2011
Enrollment StartNov 1, 2010
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 15.3 years ago

Interventions

Open heart surgeryother

TCD count of microembolic signals during surgical aortic valve replacement