CO2 Modulation in Endovascular Thrombectomy for Acute Ischemic Stroke

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Clermont-Ferrand

About this trial

Acute ischemic stroke due to large vessel occlusion is responsible of cerebral blood flow impairment with a progressive and extensive ischemic process. Cerebral collateral circulation may preserve an ischemic penumbra that could recover providing timely reperfusion of the occluded vessel. Mechanical thrombectomy is the standard of care for anterior circulation large vessel reperfusion. Strategy to promote cerebral blood flow in collateral circulation before reperfusion is scarce and rely mainly on blood pressure maintenance. Carbon dioxide is a potent cerebral vasodilator that could enhance collateral circulation blood flow and cerebral protection before reperfusion. General anesthesia with endotracheal mechanical ventilation could be used for thrombectomy and give the opportunity to modulate and control carbon dioxide tension in the blood. This study will test the effect of moderate hypercapnia on penumbral collateral circulation before reperfusion during mechanical thrombectomy for anterior circulation acute ischemic stroke under general anesthesia.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Active smoker

Chronic respiratory failure with ambulatory oxygen supplementation

Obesity with BMI>40Kg/ m2

Intubation before the procedure

Trial design

Design model

Parallel

Treatments tested in this trial

  • HYPERCAPNIA

    Biological/Vaccine

    Controlled moderate hypercapnia PaCO2 50mmHg under general anesthesia with mechanical ventilation

  • NORMOCAPNIA

    Biological/Vaccine

    Controlled normocapnia PaCO2 40mmHg under general anesthesia with mechanical ventilation

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: HYPERCAPNIAExperimental treatment 1 intervention
Group B: NORMOCAPNIAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

ASITN cerebral vascular collaterality score > 2

American Society of Interventional and Therapeutic Neuroradiology (ASITN) cerebral vascular collaterality score ranges from 0 (no collaterals visible to the ischemic site) to 4 (complete and rapid collateral blood flow to the vascular bed in the entire ischemic territory by retrograde perfusion). A score \> 2 indicate at least collaterals with slow but complete angiographic blood flow of the ischemic bed by the late venous phase.

Time frame
Before reperfusion of the occluded vessel

Secondary outcomes

1

ASITN cerebral vascular collaterality score

American Society of Interventional and Therapeutic Neuroradiology (ASITN) variation during the procedure

Time frame
• At initial angiography in normocapnia and • Before reperfusion at randomized arterial CO2 tension level
2

Volume of cerebral infarction

Evaluated with Magnetic Resonance Imaging in milliliters

Time frame
24 hours after stroke
3

Progression of cerebral infarction

Evaluated with Magnetic Resonance Imaging or Computed Tomography in milliliters depending on type of radiological modality for patient selection

Time frame
24 hours after stroke
4

Neurological clinical outcome

Ordinal and dichotomized modified rankin scale (mRS) ranging from 0 (no disability) to 6 (death); good outcome will be defined as mRS 0-2.

Time frame
3 months

Other outcomes

1

Pial Vascular Collaterality within the symptomatic ischemic territory at admission

Pial Vascular collaterality evaluated at admission with CT or MRI during patient selection for thrombectomy using the Pial Arterial Filling Score (from 0 indicated no collaterality to 5 indicating excellent collaterality)

Time frame
At admission
2

Arterial carbon dioxide tension

Arterial carbon dioxide tension will be measured at 2 time points.

Time frame
At groin puncture and at the end of procedure
3

Cerebral infarction extension

The Alberta Stroke Program Early Computed Tomography Score (ASPECTS) is an imaging measure of the extent of ischemic stroke. Scores range from 0 to 10, with higher scores indicating a smaller infarct core.

Time frame
Before thrombectomy and at day 1
4

Reperfusion assessed by mTICI

The modified Treatment In Cerebral Ischemia (mTICI) reperfusion scale ranging from 0 (no perfusion) to 3 (full perfusion with filling of all distal Branches). Good reperfusion will be defined as a score of 2B-3.

Time frame
End of procedure

Sponsors and contacts

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