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

NCT01319799 | Completed Results

• 1 other identifier: Dnr112-09
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Stenosis

Keywords

Embolism; Nervous system; Aorta; Valves; Ultrasonics

Outcome Measures

Primary Outcomes (1)

• Transcranial Doppler(TCD) Microembolic Signals During Surgical Aortic Valve Replacement Surgery

  Transcranial Doppler measurement of microembolic signals will be measured during the surgical procedure.Microembolic signals are detected by offline analysis of the Dopplerspectral analysis of the blood flow in the medial cerebral artery. Different intensities (dB),flow direction and time frame appearances in the Doppler spectral envelope is distinguishable for a neurosonolgist according to predefined criteria for an embolic signal-defined in previous litterature.The total amount of signals during one surgical procedure is counted. The appearance of microembolic signals related to specific procedures performed during cardiac surgery with cardiopulmonary bypass is noted. The exact time range is not possible to estimate in advance,due to the fact that each surgical procedure varies in time.The range of values for each individual patient, based on pilos, will vary from 50 to approximately 1500 embolic counts for one surgical procedure. A high value is negative for the patient.

  (day 1) TCD will be performed from start of surgery till end of surgery-exact time cannot be stated in advance

Secondary Outcomes (1)

• Cerebrospinal Fluid(CSF) Levels of S-100B(Microgram/Liter)

  24 Hours after Surgery

Study Arms (1)

Surgical aortic valve replacement

Single observational study. Count of microembolic signals during open heart surgery and measurement of properative vs postoperative levels of markers in cerebrospinal fluid of neuronal damge.

Other: Open heart surgery

Interventions

Open heart surgery OTHER

TCD count of microembolic signals during surgical aortic valve replacement

Surgical aortic valve replacement

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Elective surgical aortic valve replacement

You may qualify if:

• Clinical diagnosis aortic stenosis eligible for surgical treatment

You may not qualify if:

• Coagulopathy
• Regular Anticoagulation therapy
• Carotid stenosis

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Department of Thoracic Anaesthesia & Intensive Care,Sahlgrenska University Hospital

Gothenburg, 41345, Sweden

Location

Related Publications (6)

• Stolz E, Gerriets T, Kluge A, Klovekorn WP, Kaps M, Bachmann G. Diffusion-weighted magnetic resonance imaging and neurobiochemical markers after aortic valve replacement: implications for future neuroprotective trials? Stroke. 2004 Apr;35(4):888-92. doi: 10.1161/01.STR.0000120306.82787.5A. Epub 2004 Feb 19.

  PMID: 14976326 BACKGROUND

• Abu-Omar Y, Balacumaraswami L, Pigott DW, Matthews PM, Taggart DP. Solid and gaseous cerebral microembolization during off-pump, on-pump, and open cardiac surgery procedures. J Thorac Cardiovasc Surg. 2004 Jun;127(6):1759-65. doi: 10.1016/j.jtcvs.2003.09.048.

  PMID: 15173734 BACKGROUND

• Kruis RW, Vlasveld FA, Van Dijk D. The (un)importance of cerebral microemboli. Semin Cardiothorac Vasc Anesth. 2010 Jun;14(2):111-8. doi: 10.1177/1089253210370903.

  PMID: 20478951 BACKGROUND

• van Dijk D, Kalkman CJ. Why are cerebral microemboli not associated with cognitive decline? Anesth Analg. 2009 Oct;109(4):1006-8. doi: 10.1213/ANE.0b013e3181b5af06. No abstract available.

  PMID: 19762723 BACKGROUND

• Martin KK, Wigginton JB, Babikian VL, Pochay VE, Crittenden MD, Rudolph JL. Intraoperative cerebral high-intensity transient signals and postoperative cognitive function: a systematic review. Am J Surg. 2009 Jan;197(1):55-63. doi: 10.1016/j.amjsurg.2007.12.060. Epub 2008 Aug 23.

  PMID: 18723157 BACKGROUND

• Anderson RE, Hansson LO, Nilsson O, Liska J, Settergren G, Vaage J. Increase in serum S100A1-B and S100BB during cardiac surgery arises from extracerebral sources. Ann Thorac Surg. 2001 May;71(5):1512-7. doi: 10.1016/s0003-4975(01)02399-2.

  PMID: 11383792 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid levels of S100B, NSE , Tau and albumin detected by elctrochemoluminescence immunoassay.

MeSH Terms

Conditions

Aortic Valve Stenosis; Embolism; Neurologic Manifestations

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Embolism and Thrombosis; Vascular Diseases; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

100 patients asked for participation; 10 accepted. Large outcome in descriptive study- Ended after 10 cases

Results Point of Contact

• Title: Dr Bjorn Reinsfelt
• Organization: Sahlgrenska University Hospital,Cardiothoracic Anesthesia, 41345 Gothenburg ,SWEDEN

bjorn.reinsfelt@gu.se

0046702954263

Study Officials

• Sven Erik Ricksten, Professor

  Sahlgrenska University Hospital,Thoracic Anesthesia & Intensive Care

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant MD, PhD,Cardiothoracic Anaesthesia

Study Record Dates

• First Submitted: March 21, 2011
• First Posted: March 22, 2011
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: March 29, 2017
• Results First Posted: March 29, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)