Comparing Between CO2 and Phenylephrine Treatment in Pati... | NCT04839224

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

NCT04839224

Sponsor

Yonsei University

Status

Terminated

Last Update Posted

Jan 14, 2025Actual

Enrollment

3Actual

Phase

Phase 3

Conditions

Acute Ischemic Stroke

Interventions

carbogen
phenylephrine

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Slow Patient Enrollment

Expanded Access Info

Start Date

Apr 5, 2021Actual

Primary Completion Date

Oct 18, 2022Actual

Completion Date

Sep 12, 2024Actual

First Submitted Date

Apr 6, 2021

First Submission Date that Met QC Criteria

Apr 8, 2021

First Posted Date

Apr 9, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 12, 2025

Last Update Posted Date

Jan 14, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Carbogen group	Experimental		Drug: carbogen
Phenylephrine group	Active Comparator		Drug: phenylephrine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
carbogen	Drug	Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes.	Carbogen group

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Comparison between groups by percent improvement of NIHSS score	(baseline NIHSS score-post-treatment NIHSS score)/baseline NIHSS score×100	48 hours
Comparison between groups by difference of NIHSS score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age ≥20 years
Anterior circulation progressive lacunar infarction.
Neurological worsening either 1 point in NIHSS score or MRC grade

Exclusion Criteria:

Age <20
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei University Health System, Severance Hospital		Seoul			South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D059409	Stroke, Lacunar

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C011700	carbogen
D010656	Phenylephrine

Ancestor Terms

ID	Term
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided

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.