CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients (CANCCAP)
Primary Purpose
Cardiac Arrest
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
CT Perfusion
Sponsored by
About this trial
This is an interventional diagnostic trial for Cardiac Arrest focused on measuring Comatose cardiac arrest patients, Computed Tomographic Perfusion, Targeted Temperature Management, Out of hospital cardiac arrest
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Sites / Locations
- St. Boniface HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Comatose cardiac arrest patients
Arm Description
Comatose cardiac arrest patients will be undergoing CT perfusion test
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04323020
First Posted
March 17, 2020
Last Updated
June 9, 2022
Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04323020
Brief Title
CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients
Acronym
CANCCAP
Official Title
CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients (CANCCAP)-a Prospective Cohort Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Manitoba Medical Service Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest
Keywords
Comatose cardiac arrest patients, Computed Tomographic Perfusion, Targeted Temperature Management, Out of hospital cardiac arrest
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
Participant will be comatose cardiac arrest
Allocation
N/A
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Comatose cardiac arrest patients
Arm Type
Experimental
Arm Description
Comatose cardiac arrest patients will be undergoing CT perfusion test
Intervention Type
Diagnostic Test
Intervention Name(s)
CT Perfusion
Intervention Description
CT Perfusion
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jai Shankar, MD FRCPC
Phone
4313734164
Email
shivajai1@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Susan K Alcock, MN
Phone
2047893996
Email
salcock@hsc.mb.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jai Shankar, MD FRCPC
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Boniface Hospital
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2H 2A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan Schaffer, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients
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