CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN

Yonsei University

Status and phase

Not yet enrolling

Phase 3

Conditions

Acute Ischemic Stroke

Treatments

Drug: phenylephrine

Drug: carbogen with or without phenyleprhine

Study type

Interventional

Funder types

Other

Identifiers

NCT06770426

4-2024-1415

Details and patient eligibility

About

Progressing stroke is associated poor functional outcome and neurological deficit.

Currently, no treatment for progressing stroke is recommended on the guideline.

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.

Increased cerebral blood flow following dilation of cerebral arteriole by CO2 might halt and revert progressing stroke.

Induced hypertension is alternative treatment of progressing stroke. 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 + phenyleprhine versus phenlyephrine in progressing stroke patients.

Enrollment

40 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age ≥20 years
Anterior circulation progressing stroke
Neurological worsening either 1 point in NIHSS score or MRC grade

Exclusion criteria

Age under 20 years.
Patients with cerebral infarction who are at risk of cerebral edema as determined by the investigator.
Patients with Moyamoya disease.
Patients with severe cerebrovascular reactivity (CVR) impairment due to cerebral vascular stenosis, making study participation challenging as determined by the investigator.
Patients unable to undergo CO2 treatment (e.g., panic disorder, anxiety disorders, or other psychiatric conditions).
Patients with hypersensitivity to phenylephrine.
Patients with persistent bradycardia (heart rate < 50 bpm).
Patients with a history of hemorrhagic stroke or at risk of cerebral hemorrhage.
Patients with a pre-stroke modified Rankin Scale (mRS) score ≥ 2, indicating impaired functional independence.
Patients ineligible for phenylephrine treatment due to any of the following:

Myocardial infarction or unstable angina within the past 3 months. Cardiac ejection fraction < 25%. Ventricular arrhythmia. Systolic blood pressure > 200 mmHg. Serum creatinine > 2 mg/dL. Pregnancy.