NCT06770426Not yet recruitingPhase 3
CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN
CompARing Between CO2 Phenylephrine and Phenylephrine Only Treatment in Patients With proGrEssing Cerebral infarctioN(CARBOGEN Trial)
Source: ClinicalTrials.gov · Last updated 20 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 7 Jan 2025
- Start date
- Feb 2025
- Primary completion date
- Sept 2027
- Lead sponsor
- Yonsei University
- Diseases
- Stroke
- NCT number
- NCT06770426
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 40
- From Feb 2025 to the primary completion date, Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of monoamine oxidase (MAO) inhibitors.
Other illness
- 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.
Lab values
- 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.
Age
- Age under 20 years.
Other
- Patients with cerebral infarction who are at risk of cerebral edema as determined by the investigator.
- Patients who do not consent to participate in the study.
Who the study is looking for
- Age ≥20 years
- Anterior circulation progressing stroke
- Neurological worsening either 1 point in NIHSS score or MRC grade
Age in the registry: 20 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Yonsei University Health System, Severance Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.