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

Acute Ischemic Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04839224
• Other study ID #: 4-2020-1491
• Status: Recruiting
• Phase: Phase 3
• Start date: April 5, 2021
• Est. completion date: March 2023

Study information

• Verified date: May 2021
• Source: Yonsei University
• Contact: Hyo Suk Nam, MD, PhD
• Phone: 82-2-2228-1617
• Email: HSNAM[@]yuhs.ac
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Infarction
• Stroke, Lacunar

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	percent improvement of NIHSS score in each group	(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100	48 hours
Primary	difference of NIHSS score in each group	baseline NIHSS score-post-treatment NIHSS score	48 hours
Primary	percent improvement of MRC score in each group	(baseline MRC score-post-treatment MRC score)/baseline MRC score×100	within 48 hours
Primary	difference of MRC score in each group	baseline MRC score-post-treatment MRC score	within 48 hours
Primary	Safety outcome: Side effect	Side effect (cerebral hemorrhage, myocardial infarction, Losing consciousness, difficulty breathing, dizziness, fatigue, headache, anxiety, etc)	within 7 days
Primary	Safety outcome: discontinuing patients	Number of discontinuing patients due to side effects	within 7 days
Secondary	Comparison between groups by percent improvement of NIHSS score	(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100	48 hours
Secondary	Comparison between groups by difference of NIHSS score	baseline NIHSS score-post-treatment NIHSS score	48 hours
Secondary	Comparison between groups by percent improvement in MRC score	(baseline MRC score-post-treatment MRC score)/baseline MRC score×100	within 48 hours
Secondary	Comparison between groups by difference of MRC score	baseline MRC score-post-treatment MRC score	within 48 hours
Secondary	Functional independence	modified Rankin score 0 to 2	upon discharge, 3 months after onset