Special Imaging Technique to Aid in the Diagnosis of Patients in Coma After Cardiac Arrest

NCT02102945 | Completed

• 1 other identifier: CTP2
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

In the present pilot study, the investigators propose to determine if performing CT perfusion scans in post-cardiac arrest patients in coma will help prognosticate the outcome in these patients.

Conditions

Brain Death

Keywords

Computed tomography; Perfusion imaging; Coma; Heart arrest; Brain death

Outcome Measures

Primary Outcomes (1)

• Clinical evaluation of brainstem function

  Clinical evaluation of brainstem function at the end of hospital stay.

  1 year

Secondary Outcomes (1)

• Number of adverse events as a measure of safety and tolerability

  30 days

Study Arms (1)

Computed tomography perfusion

OTHER

Participants will undergo CT perfusion of the head after cooling following cardiac arrest.

Procedure: Computed tomography perfusion

Interventions

Computed tomography perfusion PROCEDURE

Computed tomography perfusion of the head

Computed tomography perfusion

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients (age range: 18-80 years), in a coma for at least 24 hours following cardiac arrest who are admitted to our cardiac intensive care unit and who have recovered body temperature back to normal after being subjected to the therapeutic hypothermia protocol will be included in the study.
• Also included are those patients whose next of kin have provided consent for the study.

You may not qualify if:

• patients who are pregnant,
• those with impaired renal function,
• those who have contraindications to the CT contrast media (such as a known allergy or anaphylactic reactions) and
• those who do not provide consent. Pregnant patients will be excluded to avoid any potential adverse effect of radiation from CT perfusion study on the developing foetus. A developing foetus is more vulnerable to radiation when compared to adult patients.
• Patients above 80 years will be excluded to avoid age related comorbidities affecting the patients' survival.
• We do not see patients below 18 years of age at our institution thus they will be excluded.

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Queen Elizabeth II Health Sciences Centre-Halifax Infirmary

Halifax, Nova Scotia, B3H 3A6, Canada

Location

MeSH Terms

Conditions

Brain Death; Coma; Heart Arrest

Interventions

Cytidine Triphosphate

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Unconsciousness; Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cytosine Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Jai JS Shankar, MD, DM

  Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 3, 2014
• Study Start: June 9, 2014
• Primary Completion: May 23, 2018
• Study Completion: May 23, 2018
• Last Updated: August 21, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)