Cardiac ArrestNCT05966389
Functional MRI to Assess Brain Damage in Cardiac Arrest Patients
An observational study of Cardiac Arrest and Brain Injuries, run by Capital Medical University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cardiac Arrest, Brain Injuries
- How many people
- 31 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2021to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Cerebral Microcirculation, Blood-brain Barrier, and Cerebral Oxygenation Damage in Patients with Cardiac Arrest Using Functional MRI
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.
- Conditions
- Cardiac Arrest, Brain Injuries
- Being tested
- No interventions
- Keywords
- Cardiac arrest, functional Magnetic Resonance Imaging, cerebral microcirculation, blood-brain barrier, cerebral oxygenation
- Medical subject headings
- Heart Arrest, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionsOther
No interventions
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurologic prognosis
Patients will be followed up for neurologic prognosis according to the Modified Rankin Scale (mRS) at 6 months after disease onset.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start1 Jan 2021
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tang Ziren, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966389
- Sponsor's protocol ID
- 2023-6-21-8
- Status last verified
- Oct 2024
- First submitted
- 18 Jul 2023
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
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.
PubMed 39095884
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Cerebral Microcirculation, Blood-brain Barrier, and Cerebral Oxygenation Damage in Patients with Cardiac Arrest Using Functional MRI
- ClinicalTrials.gov ID
- NCT05966389
- Acronym / sponsor ID
- 2023-6-21-8
- Conditions
- Cardiac Arrest, Brain Injuries
- Keywords
- Cardiac arrest, functional Magnetic Resonance Imaging, cerebral microcirculation, blood-brain barrier, cerebral oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after successful cardiopulmonary resuscitation (CPR) were transferred to the emergency intensive care unit for further standardized management.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionsNo interventions | Other | – |
Primary outcome
Neurologic prognosis
Time frame: 6 months
Patients will be followed up for neurologic prognosis according to the Modified Rankin Scale (mRS) at 6 months after disease onset.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2024.
- Derived from this study: PubMed 39095884Shao 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Brain Injuries, run by Capital Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurologic prognosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05966389, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2024.