NCT05966389

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 28, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2024

Completed
Last Updated

October 8, 2024

Status Verified

October 1, 2024

Enrollment Period

3.1 years

First QC Date

July 18, 2023

Last Update Submit

October 6, 2024

Conditions

Keywords

Cardiac arrestfunctional Magnetic Resonance Imagingcerebral microcirculationblood-brain barriercerebral oxygenation

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

No interventions

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beijing chaoyang hospital

Beijing, Beijing Municipality, 100020, China

Location

Related Publications (1)

  • Shao R, Wang T, Hang C, An L, Wang X, Zhang L, Yu J, Shan Z, Yang Q, Tang Z. Alteration in early resting-state functional MRI activity in comatose survivors of cardiac arrest: a prospective cohort study. Crit Care. 2024 Aug 2;28(1):260. doi: 10.1186/s13054-024-05045-4.

MeSH Terms

Conditions

Heart ArrestBrain Injuries

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2023

First Posted

July 28, 2023

Study Start

January 1, 2021

Primary Completion

January 31, 2024

Study Completion

January 31, 2024

Last Updated

October 8, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will share

all IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
starting 6 months after publication
Access Criteria
The de-identified survey data will be made available for research purposes by contacting the corresponding authors

Locations