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

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

Sponsors

Lead Sponsor: Yonsei University

Source 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.

Overall Status Recruiting
Start Date 2021-04-05
Completion Date 2023-03-01
Primary Completion Date 2022-12-01
Phase Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
percent improvement of NIHSS score in each group 48 hours
difference of NIHSS score in each group 48 hours
percent improvement of MRC score in each group within 48 hours
difference of MRC score in each group within 48 hours
Safety outcome: Side effect within 7 days
Safety outcome: discontinuing patients within 7 days
Secondary Outcome
Measure Time Frame
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
Enrollment 40
Condition
Intervention

Intervention Type: Drug

Intervention Name: carbogen

Description: Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes.

Arm Group Label: Carbogen group

Intervention Type: Drug

Intervention Name: phenylephrine

Description: Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.

Arm Group Label: Phenylephrine group

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

20 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Hyo Suk Nam, MD, PhD Principal Investigator Department of Neurology, Yonsei University College of Medicine
Overall Contact

Last Name: Hyo Suk Nam, MD, PhD

Phone: 82-2-2228-1617

Email: [email protected]

Location
Facility: Status: Contact: Yonsei University Health System, Severance Hospital Hyo Suk Nam, MD, PhD 82-2-2228-1617 [email protected]
Location Countries

Korea, Republic of

Verification Date

2021-05-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Carbogen group

Type: Experimental

Label: Phenylephrine group

Type: Active Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: The study is a single center, prospective, randomized, open-label trial with blinded end-point assessment (PROBE) design study. For the patients with neurological worsening after lacunar infarction, the carbogen group and the phenylephrine group will be randomized by 1: 1. Patients will be enrolled from April 2021 to December 2022 (based on the date of stroke). We will collect medical history, laboratory findings, neurological scores, and functional recovery. Functional recovery scores are performed by independent researchers in the blind state. All data is collected using e-CRF, and the image study will be anonymized and sent to the central adjudication. Central adjudication will review the image study.

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.

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