CT Perfusion (CTP) for Assessment of Poor Neurological Outcome in Comatose Cardiac Arrest Patients

NCT04323020 | Completed

• 1 other identifier: HS23646 (B2020:017)
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

Comatose cardiac arrest patients; Computed Tomographic Perfusion; Targeted Temperature Management; Out of hospital cardiac arrest

Outcome Measures

Primary Outcomes (1)

• 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.

  48 hours

Study Arms (1)

Comatose cardiac arrest patients

EXPERIMENTAL

Comatose cardiac arrest patients will be undergoing CT perfusion test

Diagnostic Test: CT Perfusion

Interventions

CT Perfusion DIAGNOSTIC_TEST

CT Perfusion

Comatose cardiac arrest patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Manitoba: lead
• Manitoba Medical Service Foundation: collaborator

Study Sites (1)

St. Boniface Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (1)

• 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.

  PMID: 37270194 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Jai Shankar, MD FRCPC

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant will be comatose cardiac arrest
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 26, 2020
• Study Start: May 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: December 31, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)