Objective 1: To prospectively evaluate the utility of C-FLOW monitor to examine status of regional CBF and reperfusion in patients presenting with acute anterior circulation ischemic stroke syndrome. Objective 2: To assess the feasibility,…
ID
Source
Brief title
Condition
- Central nervous system vascular disorders
- Embolism and thrombosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Objective 1: the sensitivity and specificity of C-FLOW measurements in
detecting regional changes in CBF, perfusion, and recanalization status
compared with CTA or MRA using the modified Arterial Occlusive Lesion (mAOL)
score, or DSA using the Thrombolysis In Cerebral Infarction (TICI) score.
Objective 2: the feasibility, tolerability, and safety of C-FLOW monitoring
will be assessed using the following measures
1) Assessment of the feasibility of C-FLOW monitoring will be based on the
number of patients who complete >75% of the monitoring period with a good
quality of signal. We will use the signal quality algorithm to evaluate the
quality of signals during monitoring. The C-FLOW signals will be evaluated off
line using an automatic algorithm based on machine learning that produces a
general quality score of each probe & an evaluation of the duration of low
quality signals.
2) Safety of the device will be assessed by the incidence of device related AEs
and SAEs.
3) Tolerability will be assessed by the number of patients who are unable to
complete the full monitoring period due to device intolerability, for example
due to skin irritation, discomfort, or pain.
Secondary outcome
1. Evaluate changes in C-FLOW in comparison to clinical improvement will be
defined as a reduction of NIHSS score *10 points compared to baseline, or NIHSS
*3.
2. Evaluate changes in C-FLOW in comparison to Modified Rankin Scale score at
90-days will be dichotomized to define good outcome as mRS *2. We will also
determine the overall distribution of scores on mRS.
Background summary
Endovascular therapy remains a viable option in a select group of AIS patients
with evidence of a large vessel occlusion as suggested by the recent results of
the Multicenter Randomized Clinical trial of Endovascular treatment for Acute
ischemic stroke in the Netherlands (MRCLEAN). Early detection of AIS patients
who do not achieve arterial recanalization/reperfusion after iV rt-PA is an
essential part of clinical decision making. Currently, most stroke centers
would obtain advanced vascular imaging, such as CTA, MRA or DSA. However, they
are expensive, time-consuming, invasive, and may not be readily available in a
timely manner, or may expose some patients to the risk of unnecessary radiation
or contrast administration.
There is an unmet need for a simple, inexpensive, non-invasive, and reliable
tool to monitor the status of cerebral blood flow in AIS who are treated with
systemic thrombolysis in real time to facilitatie rapid assessment of the brain
perfusion status at the bedside and to rapidly identify potential candidates
for endovascular intervention.
The Ornim C-FLOW ultrasound tagged near infrared spectroscopy (NIRS) monitor is
a promising candidate. It enables non-invasive and instantaneous localized
measurements from the brain tissue at the bedside and has been shown to
estimate changes in cerebral blood flow (CBF) and to correlate with 133 Xenon
SPECT measurements of cerebral blood flow.
We hypothesize that Ornim C-FLOW can be valuable in monitoring AIS patients
during thrombolysis to determine whether early arterial recanalization and
reperfusion occur by providing information about changes in CBF in specific
regions of the brain.
Study objective
Objective 1: To prospectively evaluate the utility of C-FLOW monitor to examine
status of regional CBF and reperfusion in patients presenting with acute
anterior circulation ischemic stroke syndrome.
Objective 2: To assess the feasibility, tolerability and safety of the C-FLOW
monitor in AIS patients.
Study design
In order to test our hypothesis, we propose an investigator-initiated,
prospective, observational, pilot study to validate this monitoring technique
in estimating relative regional changes of CBF, and hence recanalization
status, by comparing the information gained by the C-FLOW with neurological
status assessed by NIHSS score, and vascular imaging data from CTA, MRA, or DSA
in a cohort of anterior circulation cortical AIS patients who are treated with
reperfusion therapy including thrombolysis.
Study burden and risks
The C-Flow monitor is non-invasive, and largely well-tolerated. The device
probes will be positioned via an adhesive tape to the scalp over the forehead,
and there is a slight chance for transient and mild skin irritation. We will
repeatedly check for pain/discomfort and for any signs of skin irritation
during the monitoring period, and could end the monitoring if there is
persistent severe pain or irritation. Our previous experience, the
non-invasive nature of the proposed studies, the general acceptance by
practicing physicians of the procedures to be used, and the close supervision
and monitoring of subjects all minimize the potential risks.
Atir Yeda Street 15
Kfar Saba 4464312
IL
Atir Yeda Street 15
Kfar Saba 4464312
IL
Listed location countries
Age
Inclusion criteria
1. Patients presenting with anterior circulation ischemic stroke syndrome
2. Patients meeting the eligibility criteria for IV rt-PA and/ or EVT
3. Patients undergoing pre-treatment vascular imaging as part of their stroke evaluation;CTA/MRA
4. Baseline CTA or MRA confirming the presence of an anterior circulation arterial proximal occlusion (ACA, MCA including M1 or M2, or ICA)
5. Age *18 years
6. Informed consent is obtained from the subject or his/her representative (deferred consent).
Exclusion criteria
1. Posterior circulation stroke
2. Absolute contraindications for CTA, MRA, or DSA
3. Lacerations or skin defects at the forehead area where sensors should be placed
4. Brain CT-scan (or MRI) showing hemorrhage
5. Investigator determination that subject is not a potential candidate for an endovascular. intervention.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL52101.078.15 |