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

Phase 3

Terminated

• Conditions: Acute Ischemic Stroke
• Interventions: Drug: carbogen; Drug: phenylephrine

• Registration Number: NCT04839224
• Lead Sponsor: Yonsei University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-05
• Study First Submitted: 2021-04-06
• Study First Submitted QC: 2021-04-08
• Study First Posted: 2021-04-09
• Primary Completion: 2022-10-18
• Study Completion: 2024-09-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-12
• Last Update Posted: 2025-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carbogen group	carbogen	-
Phenylephrine group	phenylephrine	-

Primary Outcome Measures

Name	Time	Method
Safety outcome: Side effect	within 7 days	Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
Safety outcome: discontinuing patients	within 7 days	Number of discontinuing patients due to side effects
percent improvement of NIHSS score in each group	48 hours	(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
difference of NIHSS score in each group	48 hours	baseline NIHSS score-post-treatment NIHSS score
percent improvement of MRC score in each group	within 48 hours	(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
difference of MRC score in each group	within 48 hours	baseline MRC score-post-treatment MRC score

Secondary Outcome Measures

Name	Time	Method
Comparison between groups by percent improvement of NIHSS score	48 hours	(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
Comparison between groups by difference of NIHSS score	48 hours	baseline NIHSS score-post-treatment NIHSS score
Comparison between groups by percent improvement in MRC score	within 48 hours	(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
Comparison between groups by difference of MRC score	within 48 hours	baseline MRC score-post-treatment MRC score
Functional independence	upon discharge, 3 months after onset	modified Rankin score 0 to 2

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of