Functional MRI to Assess Brain Damage in Cardiac Arrest Patients

Sponsor
Capital Medical University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05966389
Collaborator
(none)
30
1
36
0.8

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: No interventions

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Assessment of Cerebral Microcirculation, Blood-brain Barrier, and Cerebral Oxygenation Damage in Patients With Cardiac Arrest Using Functional MRI
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Jan 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Neurologic prognosis [6 months]

    Patients will be followed up for neurologic prognosis according to the Modified Rankin Scale (mRS) at 6 months after disease onset.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Beijing chaoyang hospital Beijing Beijing China 100020

Sponsors and Collaborators

  • Capital Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tang Ziren, Professor, Capital Medical University
ClinicalTrials.gov Identifier:
NCT05966389
Other Study ID Numbers:
  • 2023-6-21-8
First Posted:
Jul 28, 2023
Last Update Posted:
Jul 28, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tang Ziren, Professor, Capital Medical University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 28, 2023