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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05966389
Other study ID # 2023-6-21-8
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date January 2024

Study information

Verified date July 2023
Source Capital Medical University
Contact Ziren Tang, Ph.D
Phone +86 010-85231530
Email tangziren1970@163.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a single-center, observational study. Patients after successful cardiopulmonary resuscitation (CPR) will be transferred to the emergency intensive care unit for further standardized management. After successful return of spontaneous circulation (ROSC) for 72h and hemodynamics remained stable for 24h, the post-resuscitated patients underwent functional magnetic resonance imaging (fMRI) examination. During the examination, the supervising physician accompanied the patient and monitored the patient's vital signs using a magnetic resonance monitoring system (Siemens Healthcare Prism, Germany). Patients who are on ventilators are mechanically ventilated using a magnetic ventilator (HAMILTON-MRI, USA). In additional to conventional sequences, fMRI is performed for diffusion-prepared pseudo-continuous arterial spin labeling (DP-pCASL) and blood oxygenation level dependent functional magnetic resonance imaging (BOLD-fMRI). These MRI sequences allow quantitative assessment of the patients' cerebral microcirculation, blood-brain barrier, and cerebral oxygenation status. Patients will be followed up for neurologic prognosis according to the Modified Rankin Scale (mRS) at 6 months after disease onset.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - age =18 years. - sustained hemodynamic stability for =24h. - the patients were unconscious and not able to obey verbal commands. - Advanced life support and target temperature management within 6 hours of return of spontaneous circulation (ROSC). Exclusion Criteria: - Patients with hemodynamic instability. - Patients who could not complete cranial MRI examination for special reasons. - Patients during pregnancy. - Patients who combined traumatic brain injury, stroke, cerebral hemorrhage and other diseases. - Patients whose family members did not agree to be enrolled.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
No interventions
No interventions

Locations

Country Name City State
China Beijing chaoyang hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neurologic prognosis Patients will be followed up for neurologic prognosis according to the Modified Rankin Scale (mRS) at 6 months after disease onset. 6 months
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