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CompletedNCT02102945Updated Aug 21, 2024

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

An interventional study of Computed tomography perfusion in Brain Death, sponsored by Nova Scotia Health Authority. Completed at 1 site in Canada. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-08-21.

Sponsored by Nova Scotia Health Authority · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
5
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the detailed description

Cardiac arrest is common and is associated with poor survival despite intensive medical care. These patients are subjected to cooling therapy to improve neurological outcomes. After cooling these patients are allowed to spontaneously return to normal body temperature. From here on, the outcome of these patients is mainly dependent on a wait and watch approach as the clinical examination of patients in a coma is very limited. Despite these attempts, 41% of these patients die and only 55 % of them have a favourable neurological outcome.

There have been few clinical scoring systems to provide prognosis in the face of a cardiac arrest but none of them address the more serious group- those in coma. For patients in coma, their medications, particularly those that suppress the central nervous system, cause difficulty in their clinical assessment. Multiple ancillary tests, such as routine CT or MRI of brain, do not give any useful prognostic information. We hypothesize that the neurological outcome of patients in coma is mainly dependent on presence of brainstem function.

To the best of our knowledge, no study has addressed the issue of brainstem function in cardiac arrest patients. This may be due to the fact that there was no imaging tool which could confidently depict the function of the brainstem. In a recently performed study in our institution, using CT perfusion technique, we have demonstrated that patients with diffusely impaired brainstem perfusion have poor prognosis and do not survive. This study is already being considered by the World Health Organization for the modification of criteria for the declaration of brain death. We suggest that a similar imaging technique will potentially be useful in prognosticating patients in coma following cardiac arrest.

In the present pilot study, we propose to determine if performing CT perfusion scans in post-cardiac arrest patients in coma will help prognosticate the outcome in these patients. This may potentially help in early withdrawal of care in patients with significantly impaired brainstem function. If so, this will have a significant impact on patient care and can potentially have huge financial implications for the health care system. Such early decision making may also help in organ harvesting in suitable situations. This will potentially improve the quality of life in many other terminally ill patients.

02

Conditions studied

  • Brain Death

Keywords

  • Computed tomography
  • Perfusion imaging
  • Coma
  • Heart arrest
  • Brain death
03

In context

Brain Death

74 studies on the registry are indexed under Brain Death; 10 are open to participants now.

This study's enrollment of 5 is below the median of 154 across 39 interventional studies indexed under Brain Death.

Browse Brain Death studies →

Lead sponsor

Nova Scotia Health Authority is the lead sponsor of 264 studies on the registry; 79 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • patients who are pregnant,
  • those with impaired renal function,
  • those who have 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
5 participants (actual)

Study arms

  • Other
    Computed tomography perfusion

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

    Procedure: Computed tomography perfusion

Interventions

  • ProcedureComputed tomography perfusion

    Computed tomography perfusion of the head

06

What researchers measure

Primary outcomes

  1. Clinical evaluation of brainstem function

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

    Time frame: 1 year

Secondary outcomes

  1. Number of adverse events as a measure of safety and tolerability

    Time frame: 30 days

07

Study locations

1 site
  • Queen Elizabeth II Health Sciences Centre-Halifax Infirmary
    Halifax, Nova Scotia B3H 3A6, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02102945
Responsible party
Sponsor
First posted
Apr 3, 2014
Start date
Jun 9, 2014
Primary completion
May 23, 2018
Completion
May 23, 2018
Last update
Aug 21, 2024

Study contacts

Jai JS Shankar, MD, DM
principal investigator · Queen Elizabeth II Health Sciences Centre, Halifax Infirmary

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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