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Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain

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ClinicalTrials.gov Identifier: NCT03281395
Recruitment Status : Completed
First Posted : September 13, 2017
Last Update Posted : September 13, 2017
Sponsor:
Information provided by (Responsible Party):
Joke De Wachter, University Hospital, Antwerp

Brief Summary:
Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. It is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigator will study the safety of RVP, particularly for the heart and the brain, retrograde by studying troponin levels and magnetic resonance imaging or computed tomography.

Condition or disease Intervention/treatment
Cardiac Pacing, Artificial Aneurysm, Brain Arteriovenous Malformations, Cerebral Procedure: Rapid ventricular pacing (RVP) Procedure: No rapid ventricular pacing

Detailed Description:
Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall of blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture. In a former study blood pressure and clinical outcome were used as study parameters. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected if only clinical outcome is taken as a study parameter. In this retrograde study, the investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging or computed tomography and troponin levels. The purpose of this study is to evaluate the effect of repetitive periods of RVP on the oxygenation of the heart and brain using magnetic resonance imaging and troponin levels both markers for ischemia damage.

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Study Type : Observational
Actual Enrollment : 27 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain
Actual Study Start Date : August 30, 2011
Actual Primary Completion Date : January 15, 2013
Actual Study Completion Date : July 15, 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms MRI Scans

Group/Cohort Intervention/treatment
Cerebral aneurysm surgery with RVP
During surgery patients allocated to this group will undergo RVP. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for rapid ventricular pacing induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.
Procedure: Rapid ventricular pacing (RVP)
Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short period of time during dissection of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. RVP technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations and can be lifesaving in the case of an intraoperative bleeding or rupture.

Craniotomy without RVP
No rapid ventricular pacing is applied during surgery. Subjects receive Magnetic Resonance Imaging or Computed Tomography as standard of care, pre-and postoperatively. To screen for induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on) and fossa posterior will be evaluated. Troponin levels are determinated preoperatively and 24 hours postoperatively by blood sample as standard of care. Maximum cTnl level and cTnl level 24 hours will be compared.
Procedure: No rapid ventricular pacing



Primary Outcome Measures :
  1. Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample (baseline) [ Time Frame: A first blood sample is collected immediately preoperative in the operating room. Postoperative samples are taken at 24 hours up to 60 hours after start surgery ]
    For detection of myocardial injury, the cardiac specific enzyme Troponin(cTnl)is evaluated pre-and postoperatively


Secondary Outcome Measures :
  1. Magnetic resonance imaging or computed tomography [ Time Frame: Preoperative and within 1 week post surgery ]
    Magnetic resonance imaging or computed tomography of the brain pre-and postoperatively is used as standard of care. To screen for RVP induced micro-infarcts, the contralateral hemisphere(contralateral to the hemisphere operated on)and fossa posterior will be evaluated.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 18 years, schedulled for elective brain surgery and not responding to any of the exclusion criteria
Criteria

Inclusion Criteria

  • elective cerebral aneurysm clipping surgery
  • arteriovenous malformation surgery
  • craniotomy
  • American Society of Anesthesiologists 1,2 and 3

Exclusion Criteria:

  • cardiac abnormalities
  • coronary heart disease
  • valvular heart disease
  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03281395


Locations
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Belgium
University hospital Antwerp
Edegem, Antwerp, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Investigators
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Principal Investigator: Vera Saldien, MD University Hospital, Antwerp
Principal Investigator: Tomas Menovsky, MD, PhD University Hospital, Antwerp

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Responsible Party: Joke De Wachter, data manager, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03281395     History of Changes
Other Study ID Numbers: 17/16/205-2
First Posted: September 13, 2017    Key Record Dates
Last Update Posted: September 13, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Vascular Malformations
Central Nervous System Vascular Malformations
Aneurysm
Congenital Abnormalities
Arteriovenous Malformations
Hemangioma
Intracranial Aneurysm
Intracranial Arteriovenous Malformations
Vascular Diseases
Cardiovascular Diseases
Cardiovascular Abnormalities
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Intracranial Arterial Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nervous System Malformations