Cardiac ArrestCANCCAPNCT04323020
CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients
A study testing CT Perfusion in people with Cardiac Arrest, run by University of Manitoba at 1 site in Canada.
Trial summary
ABSTRACT Brief Overview: Neurological assessment of comatose cardiac arrest patients (CCAP) is challenging because most of these patients are treated with sedatives and therapeutic hypothermia that prevent complete neurological/clinical assessment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- CT Perfusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 31 Dec 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Newly admitted comatose adults (≥18 years old) who have suffered an Out of Hospital Cardiac Arrest (OHCA)
- Treating physicians plan on instituting post cardiac arrest Targeted Temperature Management (TTM) therapies
Who cannot join
- No substitute decision maker available for consent
- Known pregnancy
- Known contraindication to CT contrast agent, such as a history of allergy or anaphylactic reaction
- Known chronic kidney disease, stage 4-5 (eGFR < 30 mL/min/1.73 m2)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients (CANCCAP)-a Prospective Cohort Study
ABSTRACT
Brief Overview: Neurological assessment of comatose cardiac arrest patients (CCAP) is challenging because most of these patients are treated with sedatives and therapeutic hypothermia that prevent complete neurological/clinical assessment. A complete and reliable neurological assessment is needed for patient's long-term function and survival. A poor-quality clinical assessment results in resource-intensive treatment that may not benefit the patient. An ancillary test of head CT scan is often used for additional information. However, this additional information still limits the quality of the assessment. In a small pilot study, we explored an advanced CT scan of brain called CT Perfusion (CTP) relative to clinical assessment in CCAP as a predictor of neurological outcome (severe disability or death) at hospital discharge. The preliminary results suggested that CTP was both valid and reliable, relative to clinical assessment, while meeting many of the criteria of an ideal test (fast, safe, accessible, valid, reliable). This project aims to carry out a fully powered study to confirm these findings.
Read more
The goal of this project is to validate CTP for predicting neurological outcome at hospital discharge in CCAP. We will conduct a prospective cohort study to validate the use of CTP in CCAP.
Hypothesis- Computed Tomographic Perfusion (CTP) can reliably diagnose potentially fatal brain injury in CCAP in early stage upon hospital admission, which may or may not be recognized in the usual clinical practice due to inadequate clinical examination.
Primary Objective: To validate CTP, relative to the reference standard of clinical assessment, for characterizing poor neurological outcome at hospital discharge in CCAP.
Secondary Objectives:
To establish the safety and inter-rater reliability of CTP in CCAP.
Read the detailed description
This study will be conducted in our tertiary care cardiac center. The cohort will consist of newly admitted comatose adults (>18 years of age) who have suffered an OHCA and are treated with standard TTM to 36°C. Just before admission to the intensive care unit (ICU), CCAP undergo CT scan of head. Our plan is to add CTP of whole head at the time of their standard of care CT scan of head. CCAP will then be transferred to ICU for further standard management including TTM.
Immediately after acute care, CCAP usually undergo a CT scan of the head, as per standard protocol, to assess for any intracranial pathology. CTP will be performed at the same time as this standard-of-care CT scan of head. CTP images will be acquired according to a standardized stroke imaging protocol in order to ensure whole brain coverage. The CTP data will be transferred to the study imaging core lab at the department of Radiology, University of Manitoba, Winnipeg for interpretation. The CTP results will not be available to the treating physicians and the routine care of the patient will continue as per local practice.
CTP analysis will be performed in the imaging core lab using a semiautomatic deconvolution algorithm on a vendor neutral software package. CTP will be assessed both quantitatively as well as qualitatively.
- Quantitative assessment: Brain death will be defined as CBF <5 mL/100g/min and CBV <2 mL/100g in the brainstem.
- Qualitative assessment: Brain death will be defined as matched decrease of CBF and CBV in the brainstem. The perfusion maps for CBF and CBV will be assessed for binary outcome of 'dead' or 'not-dead', according to our previously published methods.
The perfusion maps will be assessed by the two independent neuroradiologists, who are blinded to each other's assessment and to the clinical history of each patient. If the two neuroradiologists disagree, a consensus agreement will be achieved for the final analysis. Consensus decision reflects the real-life scenario faced in such situations. CTP parameters (CBF and CBV) will be qualitatively assessed for the presence or absence of matched decrease of CBF and CBV.
- Conditions
- Cardiac Arrest
- Being tested
- CT Perfusion
- Keywords
- Comatose cardiac arrest patients, Computed Tomographic Perfusion, Targeted Temperature Management, Out of hospital cardiac arrest
- Medical subject headings
- Heart Arrest, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT PerfusionDiagnostic test
CT Perfusion
| Study group | Role | What they receive |
|---|---|---|
| Comatose cardiac arrest patients | Experimental | Comatose cardiac arrest patients will be undergoing CT perfusion test Receives: Diagnostic Test: CT Perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
To validate CTP, relative to the reference standard of initial clinical assessment, for predicting poor neurological outcome (≥4 on modified Rankin scale) at hospital discharge in CCAP.
The primary outcome is to check the accuracy of CTP compared to the clinical assessment in predicting the poor neurological outcome in comatose cardiac arrest patients at hospital discharge.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start1 May 2021
- Primary completion30 Nov 2023
- Study completion31 Dec 2023
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 University of ManitobaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Responsible party
- Principal investigator, Jai Shankar, University of Manitoba
- Investigators
- Jai Shankar, MD FRCPC, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04323020
- Sponsor's protocol ID
- HS23646 (B2020:017)
- Acronym
- CANCCAP
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2020
- Last updated
- 17 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Alcock S, Singh S, Wiens EJ, Singh N, Ande SR, Lampron K, Huang B, Kirkpatrick I, Trivedi A, Schaffer SA, Shankar JS. CT perfusion for Assessment of poor Neurological outcome in Comatose Cardiac Arrest Patients (CANCCAP): protocol for a prospective study. BMJ Open. 2023 Jun 2;13(6):e071166. doi: 10.1136/bmjopen-2022-071166.
PubMed 37270194
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients (CANCCAP)-a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04323020
- Acronym / sponsor ID
- CANCCAP / HS23646 (B2020:017)
- Conditions
- Cardiac Arrest
- Keywords
- Comatose cardiac arrest patients, Computed Tomographic Perfusion, Targeted Temperature Management, Out of hospital cardiac arrest
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Manitoba Medical Service Foundation
- Study start
- 1 May 2021 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 26 Mar 2020 (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.
ABSTRACT
Brief Overview: Neurological assessment of comatose cardiac arrest patients (CCAP) is challenging because most of these patients are treated with sedatives and therapeutic hypothermia that prevent complete neurological/clinical assessment. A complete and reliable neurological assessment is needed for patient's long-term function and survival. A poor-quality clinical assessment results in resource-intensive treatment that may not benefit the patient. An ancillary test of head CT scan is often used for additional information. However, this additional information still limits the quality of the assessment. In a small pilot study, we explored an advanced CT scan of brain called CT Perfusion (CTP) relative to clinical assessment in CCAP as a predictor of neurological outcome (severe disability or death) at hospital discharge. The preliminary results suggested that CTP was both valid and reliable, relative to clinical assessment, while meeting many of the criteria of an ideal test (fast, safe, accessible, valid, reliable). This project aims to carry out a fully powered study to confirm these findings.
The goal of this project is to validate CTP for predicting neurological outcome at hospital discharge in CCAP. We will conduct a prospective cohort study to validate the use of CTP in CCAP.
Hypothesis- Computed Tomographic Perfusion (CTP) can reliably diagnose potentially fatal brain injury in CCAP in early stage upon hospital admission, which may or may not be recognized in the usual clinical practice due to inadequate clinical examination.
Primary Objective: To validate CTP, relative to the reference standard of clinical assessment, for characterizing poor neurological outcome at hospital discharge in CCAP.
Secondary Objectives:
To establish the safety and inter-rater reliability of CTP in CCAP.
Detailed description
This study will be conducted in our tertiary care cardiac center. The cohort will consist of newly admitted comatose adults (>18 years of age) who have suffered an OHCA and are treated with standard TTM to 36°C. Just before admission to the intensive care unit (ICU), CCAP undergo CT scan of head. Our plan is to add CTP of whole head at the time of their standard of care CT scan of head. CCAP will then be transferred to ICU for further standard management including TTM.
Immediately after acute care, CCAP usually undergo a CT scan of the head, as per standard protocol, to assess for any intracranial pathology. CTP will be performed at the same time as this standard-of-care CT scan of head. CTP images will be acquired according to a standardized stroke imaging protocol in order to ensure whole brain coverage. The CTP data will be transferred to the study imaging core lab at the department of Radiology, University of Manitoba, Winnipeg for interpretation. The CTP results will not be available to the treating physicians and the routine care of the patient will continue as per local practice.
CTP analysis will be performed in the imaging core lab using a semiautomatic deconvolution algorithm on a vendor neutral software package. CTP will be assessed both quantitatively as well as qualitatively.
- Quantitative assessment: Brain death will be defined as CBF <5 mL/100g/min and CBV <2 mL/100g in the brainstem.
- Qualitative assessment: Brain death will be defined as matched decrease of CBF and CBV in the brainstem. The perfusion maps for CBF and CBV will be assessed for binary outcome of 'dead' or 'not-dead', according to our previously published methods.
The perfusion maps will be assessed by the two independent neuroradiologists, who are blinded to each other's assessment and to the clinical history of each patient. If the two neuroradiologists disagree, a consensus agreement will be achieved for the final analysis. Consensus decision reflects the real-life scenario faced in such situations. CTP parameters (CBF and CBV) will be qualitatively assessed for the presence or absence of matched decrease of CBF and CBV.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comatose cardiac arrest patients | Experimental | Diagnostic Test: CT PerfusionComatose cardiac arrest patients will be undergoing CT perfusion test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Newly admitted comatose adults (≥18 years old) who have suffered an Out of Hospital Cardiac Arrest (OHCA)
- Treating physicians plan on instituting post cardiac arrest Targeted Temperature Management (TTM) therapies
Key exclusion criteria (4 listed)
- No substitute decision maker available for consent
- Known pregnancy
- Known contraindication to CT contrast agent, such as a history of allergy or anaphylactic reaction
- Known chronic kidney disease, stage 4-5 (eGFR < 30 mL/min/1.73 m2)
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 |
|---|---|---|
| CT PerfusionCT Perfusion | Diagnostic test | Comatose cardiac arrest patients |
Primary outcome
To validate CTP, relative to the reference standard of initial clinical assessment, for predicting poor neurological outcome (≥4 on modified Rankin scale) at hospital discharge in CCAP.
Time frame: 48 hours
The primary outcome is to check the accuracy of CTP compared to the clinical assessment in predicting the poor neurological outcome in comatose cardiac arrest patients at hospital discharge.
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 17 Jan 2024.
- Derived from this study: PubMed 37270194Alcock S, Singh S, Wiens EJ, Singh N, Ande SR, Lampron K, Huang B, Kirkpatrick I, Trivedi A, Schaffer SA, Shankar JS. CT perfusion for Assessment of poor Neurological outcome in Comatose Cardiac Arrest Patients (CANCCAP): protocol for a prospective study. BMJ Open. 2023 Jun 2;13(6):e071166. doi: 10.1136/bmjopen-2022-071166.
- Individual participant dataSharing planned: No
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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.
Jai Shankar, MD FRCPC principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT Perfusion in people with Cardiac Arrest, run by University of Manitoba at 1 site in Canada.
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 2 inclusion and 4 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 17 Jan 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 Canada. 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?
To validate CTP, relative to the reference standard of initial clinical assessment, for predicting poor neurological outcome (≥4 on modified Rankin scale) at hospital discharge in CCAP. (time frame: 48 hours). 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 NCT04323020, 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 17 Jan 2024.