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

May 17, 2021 updated by: Yonsei University

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Hyo Suk Nam, MD, PhD
  • Phone Number: 82-2-2228-1617
  • Email: HSNAM@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:
          • Hyo Suk Nam, MD, PhD
          • Phone Number: 82-2-2228-1617
          • Email: HSNAM@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbogen group
Drug: carbogen
Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes.
Active Comparator: Phenylephrine group
Drug: phenylephrine
Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Investigators

  • Principal Investigator: Hyo Suk Nam, MD, PhD, Department of Neurology, Yonsei University College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2021

Primary Completion (Anticipated)

December 1, 2022

Study Completion (Anticipated)

March 1, 2023

Study Registration Dates

First Submitted

April 6, 2021

First Submitted That Met QC Criteria

April 8, 2021

First Posted (Actual)

April 9, 2021

Study Record Updates

Last Update Posted (Actual)

May 20, 2021

Last Update Submitted That Met QC Criteria

May 17, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2020-1491

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acute Ischemic Stroke

Clinical Trials on carbogen

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Morocco

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe