Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)
NCT ID: NCT04839224
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
3 participants
INTERVENTIONAL
2021-04-05
2024-09-12
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
2. For the patients with neurological worsening after lacunar infarction, the carbogen group and the phenylephrine group will be randomized by 1: 1.
3. Patients will be enrolled from April 2021 to December 2022 (based on the date of stroke).
4. We will collect medical history, laboratory findings, neurological scores, and functional recovery.
5. Functional recovery scores are performed by independent researchers in the blind state.
6. All data is collected using e-CRF, and the image study will be anonymized and sent to the central adjudication.
7. Central adjudication will review the image study.
TREATMENT
SINGLE
Study Groups
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Carbogen group
carbogen
Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes.
Phenylephrine group
phenylephrine
Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.
Interventions
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carbogen
Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes.
phenylephrine
Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.
Eligibility Criteria
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Inclusion Criteria
2. Anterior circulation progressive lacunar infarction.
3. Neurological worsening either 1 point in NIHSS score or MRC grade
Exclusion Criteria
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
20 Years
ALL
No
Sponsors
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Yonsei University
OTHER
Responsible Party
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Principal Investigators
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Hyo Suk Nam, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurology, Yonsei University College of Medicine
Locations
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Yonsei University Health System, Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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4-2020-1491
Identifier Type: -
Identifier Source: org_study_id
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