Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03184233
Other study ID # 17/16/205
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 14, 2017
Est. completion date December 30, 2024

Study information

Verified date May 2024
Source University Hospital, Antwerp
Contact Vera Saldien, MD
Phone 38214788
Email vera.saldien@uza.be
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 66
Est. completion date December 30, 2024
Est. primary completion date September 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Belgium University hospital Antwerp Edegem Antwerp

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. During surgery
Primary 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 6,12 and 24 hours after start surgery.
Secondary 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. Preoperative and within 1 week post surgery
Secondary Occurence of arrhythmias Any disturbances of the normal rhythmic beating of the heart or myocardial contraction. During surgery
See also
  Status Clinical Trial Phase
Recruiting NCT04994756 - Stroke Thrombectomy and Aneurysm Registry
Recruiting NCT06189014 - The International PERForator ANeurysm Registry (PERFAN)
Active, not recruiting NCT04106583 - Assessing the WAVE Extra Soft Coil in Intracranial Aneurysms and Comparing Imaging Modalities
Recruiting NCT04819074 - Prediction of Outcomes After Surgery for Unruptured Intracranial Aneurysms
Recruiting NCT04865718 - Intraoperative Laser Speckle Contrast Imaging of Cerebral Blood Flow
Not yet recruiting NCT05959759 - Dimethyl Fumarate Treatment for Intracranial Unruptured Aneurysms. Phase 4
Recruiting NCT05029947 - Setting Benchmarks for Microsurgical Clipping of Unruptured Intracranial Aneurysms
Completed NCT03889392 - Evaluation of Nephrectomy Specimen for Intracranial Aneurysm Development in ADPKD
Recruiting NCT03726463 - Evaluation of Iliac and Renal Artery for Mechanism of Intracranial Aneurysm in ADPKD
Completed NCT03281395 - Rapid Ventricular Pacing During Cerebral Aneurysm Surgery: a Retrospective Study Concerning the Safety for Heart and Brain N/A