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

Primary Purpose

Cardiac Pacing, Artificial, Aneurysm, Brain, Arteriovenous Malformations, Cerebral

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Rapid ventricular pacing
No rapid ventricular pacing
Sponsored by
University Hospital, Antwerp
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Pacing, Artificial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University hospital AntwerpRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Active Comparator

Arm Label

Cerebral aneurysm surgery with RVP

Craniotomy without RVP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Near infrared spectroscopy
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.
Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample(baseline)
For detection of myocardial injury, the cardiac specific enzyme Troponin (cTnl) is evaluated pre-and postoperatively.

Secondary Outcome Measures

Magnetic resonance imaging
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.
Occurence of arrhythmias
Any disturbances of the normal rhythmic beating of the heart or myocardial contraction.

Full Information

First Posted
June 2, 2017
Last Updated
May 12, 2023
Sponsor
University Hospital, Antwerp
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1. Study Identification

Unique Protocol Identification Number
NCT03184233
Brief Title
Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain
Official Title
Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Study Concerning the Safety for Heart and Brain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 14, 2017 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Antwerp

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Pacing, Artificial, Aneurysm, Brain, Arteriovenous Malformations, Cerebral

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
66 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cerebral aneurysm surgery with RVP
Arm Type
Other
Arm Description
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.
Arm Title
Craniotomy without RVP
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Rapid ventricular pacing
Intervention 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
Intervention Type
Procedure
Intervention Name(s)
No rapid ventricular pacing
Intervention Description
No rapid ventricular pacing is applied perioperatively.
Primary Outcome Measure Information:
Title
Near infrared spectroscopy
Description
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.
Time Frame
During surgery
Title
Change of cardiac specific enzyme Troponin (cTnl) from preoperative sample(baseline)
Description
For detection of myocardial injury, the cardiac specific enzyme Troponin (cTnl) is evaluated pre-and postoperatively.
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.
Secondary Outcome Measure Information:
Title
Magnetic resonance imaging
Description
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.
Time Frame
Preoperative and within 1 week post surgery
Title
Occurence of arrhythmias
Description
Any disturbances of the normal rhythmic beating of the heart or myocardial contraction.
Time Frame
During surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vera Saldien, MD
Phone
38214788
Ext
0032
Email
vera.saldien@uza.be
First Name & Middle Initial & Last Name or Official Title & Degree
Davina Wildemeersch, MD
Phone
38215891
Ext
0032
Email
davina.wildemeersch@uza.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vera Saldien, MD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tomas Menovsky, MD, PhD
Organizational Affiliation
University Hospital, Antwerp
Official's Role
Principal Investigator
Facility Information:
Facility Name
University hospital Antwerp
City
Edegem
State/Province
Antwerp
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Saldien, MD
Phone
3 821 4788
Ext
0032
Email
vera.saldien@uza.be
First Name & Middle Initial & Last Name & Degree
Davina Wildemeersch
Phone
3 821 58 91
Email
davina.wildemeersch@uza.be
First Name & Middle Initial & Last Name & Degree
Vera Saldien, MD
First Name & Middle Initial & Last Name & Degree
Tomas Menovsky, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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