Comparing Between CO2 and Phenylephrine Treatment in Patients With Progressive Lacunar Infarction (CARBOGEN Study)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Acute Ischemic Stroke
- Type
- Interventional
- Phase
- Phase 3
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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. Masking: Single (Outcomes Assessor)Masking Description: Three months after discharge, the independence assessment will be performed by the researcher who don't know the patients group.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 20 years and 125 years
- Gender
- Both males and females
Description
Not Provided
Not Provided
Tracking Information
- NCT #
- NCT04839224
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Hyo Suk Nam, MD, PhD Department of Neurology, Yonsei University College of Medicine