NCT03281395

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 30, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2013

Completed
4.2 years until next milestone

First Submitted

Initial submission to the registry

September 11, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2017

Completed
Last Updated

September 13, 2017

Status Verified

September 1, 2017

Enrollment Period

1.4 years

First QC Date

September 11, 2017

Last Update Submit

September 11, 2017

Conditions

Cardiac Pacing, ArtificialAneurysm, BrainArteriovenous Malformations, Cerebral

Outcome Measures

Primary Outcomes (1)

  • 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

    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

Secondary Outcomes (1)

  • Magnetic resonance imaging or computed tomography

    Preoperative and within 1 week post surgery

Study Arms (2)

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)

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

Interventions

Rapid ventricular pacing (RVP)PROCEDURE

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.

Cerebral aneurysm surgery with RVP
No rapid ventricular pacingPROCEDURE
Craniotomy without RVP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients older than 18 years, schedulled for elective brain surgery and not responding to any of the exclusion criteria

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University hospital Antwerp

Edegem, Antwerp, 2650, Belgium

Location

MeSH Terms

Conditions

Intracranial AneurysmIntracranial Arteriovenous Malformations

Condition Hierarchy (Ancestors)

Intracranial Arterial DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesAneurysmVascular DiseasesCardiovascular DiseasesCentral Nervous System Vascular MalformationsNervous System MalformationsArteriovenous MalformationsVascular MalformationsCardiovascular AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Vera Saldien, MD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

  • Tomas Menovsky, MD, PhD

    University Hospital, Antwerp

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
data manager

Study Record Dates

First Submitted

September 11, 2017

First Posted

September 13, 2017

Study Start

August 30, 2011

Primary Completion

January 15, 2013

Study Completion

July 15, 2013

Last Updated

September 13, 2017

Record last verified: 2017-09

Locations

BE(1)