Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)

Yonsei University

Status and phase: Terminated; Phase 3

Conditions: Acute Ischemic Stroke

Treatments: Drug: carbogen; Drug: phenylephrine

Study type: Interventional

Funder types: Other

Identifiers

NCT04839224

4-2020-1491

Details and patient eligibility

About

Lacunar infarction is an ischemic stroke occurred by small perforating artery occlusion . Twenty percent of ischemic stroke is lacunar infarction.

However, outcome of lacunar infarction is excellent, about 20-40% patients are suffered neurological worsening.

Progressive lacunar infarction is associated poor functional outcome and neurological deficit.

Currently, no treatment for progressive lacunar infarction is recommended on the guideline.

Several small study reported that phenylephrine and magnesium may be helpful for progressive lacunar infarction.

Carbogen is a mixture of 5% CO2 with 95% O2. Carbogen is safe and it is used for the treatment of sudden sensory neural hearing loss or ocular ischemia.

CO2 dilate cerebral arteriole and concentration of CO2 is correlated with cerebral blood flow.

Lacunar infarction is small and perfused with marginal flow by neighboring perforating arteriole.

Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressive lacunar infarction.

Induced hypertension is alternative treatment of progressive lacunar infarction. Increasing blood pressure also induce cerebral blood flow.

Phenylephrine is an α1 agonist, phenylephrine act on peripheral artery and little effect on cerebral artery or heart.

Several studies reported that the effectiveness of phenylephrine on progressing stroke.

Therefore, this study will compare the effectiveness of carbogen versus phenylephrine in lacunar infarction patients who suffered neurological worsening.

Enrollment: 3 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age ≥20 years
2. Anterior circulation progressive lacunar infarction.
3. Neurological worsening either 1 point in NIHSS score or MRC grade

Exclusion criteria

1. Age <20
2. Cortical infarction
3. Posterior circulation lacunar infarction
4. Relevant artery stenosis more than 50% or occlusion
5. Moyamoya disease
6. Difficulty in inhalation of Carbogen (panic, severe anxiety disorder)
7. Drug allergy for phenylephrine
8. Persistent bradycardia (pulse rate < 50 /min)
9. History of hemorrhagic stroke
10. Pre-stroke mRS ≥2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3 participants in 2 patient groups

Carbogen group

Experimental group

Treatment:

Drug: carbogen

Phenylephrine group

Active Comparator group

Treatment:

Drug: phenylephrine