Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- Yonsei University
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Safety outcome: Side effect
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
Three months after discharge, the independence assessment will be performed by the researcher who don't know the patients group.
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥20 years
- •Anterior circulation progressive lacunar infarction.
- •Neurological worsening either 1 point in NIHSS score or MRC grade
Exclusion Criteria
- •Cortical infarction
- •Posterior circulation lacunar infarction
- •Relevant artery stenosis more than 50% or occlusion
- •Moyamoya disease
- •Difficulty in inhalation of Carbogen (panic, severe anxiety disorder)
- •Drug allergy for phenylephrine
- •Persistent bradycardia (pulse rate < 50 /min)
- •History of hemorrhagic stroke
- •Pre-stroke mRS ≥2
Arms & Interventions
Phenylephrine group
Intervention: phenylephrine (Drug)
Carbogen group
Intervention: carbogen (Drug)
Outcomes
Primary Outcomes
Safety outcome: Side effect
Time Frame: within 7 days
Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)
Safety outcome: discontinuing patients
Time Frame: within 7 days
Number of discontinuing patients due to side effects
percent improvement of NIHSS score in each group
Time Frame: 48 hours
(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100
difference of NIHSS score in each group
Time Frame: 48 hours
baseline NIHSS score-post-treatment NIHSS score
percent improvement of MRC score in each group
Time Frame: within 48 hours
(baseline MRC score-post-treatment MRC score)/baseline MRC score×100
difference of MRC score in each group
Time Frame: within 48 hours
baseline MRC score-post-treatment MRC score
Secondary Outcomes
- Comparison between groups by percent improvement of NIHSS score(48 hours)
- Comparison between groups by difference of NIHSS score(48 hours)
- Comparison between groups by percent improvement in MRC score(within 48 hours)
- Comparison between groups by difference of MRC score(within 48 hours)
- Functional independence(upon discharge, 3 months after onset)