Functional MRI to Assess Brain Damage in Cardiac Arrest P... | NCT05966389

Studies
Functional MRI to Assess Brain Damage in Cardiac Arrest Patients

NCT05966389

Sponsor

Capital Medical University

Status

Completed

Last Update Posted

Oct 8, 2024Actual

Enrollment

31Actual

Phase

Not provided

Conditions

Cardiac Arrest
Brain Injuries

Interventions

No interventions

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2021Actual

Primary Completion Date

Jan 31, 2024Actual

Completion Date

Jan 31, 2024Actual

First Submitted Date

Jul 18, 2023

First Submission Date that Met QC Criteria

Jul 27, 2023

First Posted Date

Jul 28, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 6, 2024

Last Update Posted Date

Oct 8, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Name	Type	Description	Arm Group Labels	Other Names
No interventions	Other	No interventions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Beijing chaoyang hospital		Beijing	Beijing Municipality	100020	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39095884	Derived	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.

ID	Term
D006323	Heart Arrest
D001930	Brain Injuries

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases