aICP Measurement in Patients With Cerebral Artery Infarction / aICP MCA Infarction

NCT03641963 | Suspended DMC

• 1 other identifier: aICP Stroke
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Space-occupying, malignant middle cerebral artery (M-MCA) infarctions are still one of the most devastating forms of ischemic stroke, with a mortality of up to 80% in untreated patients. It is reported that early hemicraniectomy leads to a substantial decrease in mortality at 6 and 12 months and is likely to improve functional outcome. Thus, this study investigates if non-invasive intracranial pressure (ICP) measuring could represent an objective value to determine the time point to indicate decompressive craniectomy surgery. However, there are still important questions about the individual indication for decompressive surgery. In consideration of a variable clinical course (some patients develop fatal brain edema early, whereas other patients do not show severe brain swelling for several days), achieving a way to measure, control and predict malignant brain edema formation would be of extremely important value.

Conditions

Stroke, Acute

Outcome Measures

Primary Outcomes (1)

• Increased intracranial pressure

  The primary outcome is the non-invasive, absolute intra-cranial pressure (ICP) in M-MCA patients before decompressive surgery, as determined by the "non-invasive ICP absolute value meter" in mmHg

  24 months

Secondary Outcomes (1)

• Correlation of ICP, neuroimaging and transcranial color Doppler

  24 months

Study Arms (1)

Stroke patients with ICP measurement

EXPERIMENTAL

All patients with the possibility to evolve a malignant MCA infarct according to the initial assessment, will be included in our study, to measure ICP non-invasive. The ICP will be measured non-invasive with the Vittamed 205 Non-invasive intracranial pressure (ICP) meter.

Device: Vittamed 205 Non-invasive intracranial pressure (ICP) meter

Interventions

Vittamed 205 Non-invasive intracranial pressure (ICP) meter DEVICE

Non-Invasive intracranial pressure measurement

Stroke patients with ICP measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with an ischemic stroke in the internal carotid artery or middle cerebral artery territory at risk of a malignant MCA evolution, defined based on clinical presentation, clinical course (showing a progressive deterioration of conscious within the first 24-48 h), and neuroradiological findings.
• Age: ≥ 18 years at admission
• Informed consent of the patient or consent of patient's next of kin (plus consent of an independent physician)

You may not qualify if:

• Patients with wounds, scars including the front orbital region.
• Patients with any known ocular condition that may be worsened by sustained eye pressure.

Sponsors & Collaborators

• Kantonsspital Aarau: lead

Study Sites (1)

Kantonsspital Aarau AG

Aarau, 5001, Switzerland

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Javier Fandino

  Kantonsspital Aarau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: August 7, 2018
• First Posted: August 22, 2018
• Study Start: December 1, 2018
• Primary Completion: September 30, 2019
• Study Completion: December 31, 2021
• Last Updated: February 27, 2020

Record last verified: 2020-02

Locations

CH (1)