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

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ClinicalTrials.gov Identifier: NCT03184233
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : October 30, 2018
Sponsor:
Information provided by (Responsible Party):
Davina Wildemeersch, 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 in blood pressure which presents as an on-off phenomenon. However it is not clear whether repetitive periods of pacing are harmless for the patient. Silent cardiac and cerebral infarcts may be undetected. The investigators will study the safety of RVP, particularly for the heart and the brain.

Condition or disease Intervention/treatment Phase
Cardiac Pacing, Artificial Aneurysm, Brain Arteriovenous Malformations, Cerebral Procedure: Rapid ventricular pacing Procedure: No rapid ventricular pacing Not Applicable

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 in 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. The investigators will study the safety of RVP, particularly for the heart and the brain, using magnetic resonance imaging, brain oxygenation (Sct O₂) evaluated by near-infrared spectroscopy 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, Sct O2 (3) and troponin levels (4) both markers for ischemia damage.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Patients undergoing elective cerebral aneurysm clipping surgery or arteriovenous malformation surgery will be asked to take part and give informed consent.

A control group of patients undergoing craniotomy without the use of RVP will be built in, having the same exclusion criteria. Both study groups receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care.

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain
Actual Study Start Date : June 14, 2017
Estimated Primary Completion Date : June 3, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Arm Intervention/treatment
Cerebral aneurysm surgery with RVP
Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. 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 will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored. During surgery subjects allocated in this study arm will undergo RVP.
Procedure: Rapid ventricular pacing
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 in 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

Active Comparator: Craniotomy without RVP

Subjects receive a Magnetic Resonance Imaging of the brain pre-and postoperatively as standard of care. 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 will be determinated preoperatively, peroperative and at 6, 12 and 24 hours postoperative by blood sample. Maximum cTnl level and cTnl level 24 hours will be compared. Brain oxygenation (Sct O₂) by near-infrared spectroscopy will be monitored.

No rapid ventricular pacing is applied perioperatively.

Procedure: No rapid ventricular pacing
No rapid ventricular pacing is applied perioperatively.




Primary Outcome Measures :
  1. Near infrared spectroscopy [ Time Frame: During surgery ]
    Near infrared spectroscopy measures brain oxygenation (Sct O2), a decrease of more than 10% of the initial Sct O2 or lower than 60% during pacing will be considered as a possible risk of cerebral ischaemia.

  2. 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 6,12 and 24 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 [ Time Frame: Preoperative and within 1 week post surgery ]
    Magnetic Resonance Imaging 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.

  2. Occurence of arrhythmias [ Time Frame: During surgery ]
    Any disturbances of the normal rhythmic beating of the heart or myocardial contraction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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): NCT03184233


Contacts
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Contact: Vera Saldien, MD 38214788 ext 0032 vera.saldien@uza.be
Contact: Davina Wildemeersch, MD 38215891 ext 0032 davina.wildemeersch@uza.be

Locations
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Belgium
University hospital Antwerp Recruiting
Edegem, Antwerp, Belgium, 2650
Contact: Vera Saldien, MD    3 821 4788 ext 0032    vera.saldien@uza.be   
Contact: Davina Wildemeersch    3 821 58 91    davina.wildemeersch@uza.be   
Principal Investigator: Vera Saldien, MD         
Principal Investigator: Tomas Menovsky, MD, PhD         
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: Davina Wildemeersch, Data manager, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT03184233     History of Changes
Other Study ID Numbers: 17/16/205
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: October 30, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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