Right Ventricular DysfunctionNCT03309852
Emergency Department Assessment of Right Ventricular Function and Size in the Post Cardiac Arrest Patient
An observational study of Right Ventricular Dysfunction and Cardiac Arrest, run by University of Manitoba at 1 site in Canada.
Trial summary
The right side of the heart of often overlooked in patients who are acutely unwell, as the main area of focus when performing echocardiography tends to be the left ventricle. The right ventricle can yield important diagnostic clues that can aid the clinician, particularly in cases where one may suspect elevated right… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Right Ventricular Dysfunction, Cardiac Arrest
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- 6 Oct 2017to 31 Dec 2021
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Post cardiac arrest patients.
Who may be able to join
- Any post cardiac arrest patient who achieves return of spontaneous circulation that can have their RV assessed with point of care echo cardiography within 1 hour of ROSC.
Who cannot join
- Significant hemodynamic instability, pregnancy, incarcerated patients, age <18.
Trial locations and contacts
1 site in 1 country.
About this study
The right side of the heart of often overlooked in patients who are acutely unwell, as the main area of focus when performing echocardiography tends to be the left ventricle. The right ventricle can yield important diagnostic clues that can aid the clinician, particularly in cases where one may suspect elevated right sided pressures, such as those due to a pulmonary embolus. Although it is taught that a dilated right ventricle is associated in patients with pulmonary embolus, but in patients with spontaneous circulation. What is unknown is patients who sustain a cardiac arrest, does the same hold true. There is a paucity of literature surrounding the appearance of the right ventricle in the cardiac arrest patient acutely. This study aims to assess right ventricular size and function in the immediate post cardiac arrest phase.
Read the detailed description
The use of point of care ultrasound (PoCUS) has grown rapidly. The incorporation of PoCUS in the assessment of patients in shock and to identify a reversible etiology to a patients cardiac arrest is widely practiced and endorsed by several organizations. While often overlooked, the right ventricle (RV) plays a critical role and often can provide clues to the etiology of a patient who is in shock. The right ventricle is very unique, as its anatomic structure, and function are markedly different then the left ventricle. What is often assessed is the size of the right ventricle. If dilated, which is defined as being >0.6 times that of the left ventricle, this could be indicative of elevated right sided pressures. In the right clinical context this may be caused by an acute pulmonary embolus. While this particular finding may raise clinical suspicion of acute right ventricular strain, point of care ultrasound cannot safely rule out acute pulmonary embolism. Several publications demonstrate the use of thrombolytics if a dilated RV is seen on PoCUS. This applies in patients with cardiac function who have not sustained a cardiac arrest. But in those patients who do sustain a cardiac arrest, these patients fall into a black hole of PoCUS findings related to the right ventricle. The international liaison committee on resuscitation has urged caution due to the unknown PoCUS findings during cardiac arrest. If one were to presume a dilated RV in a setting of a patient who sustained cardiac arrest was due to a pulmonary embolus, thrombolytics would be indicated. However, exposing the patient to thrombolytics, which in themselves carry a hemorrhage risk of 20%, is not a benign decision. Thus PoCUS findings as they pertain to the RV, in patient who sustain a cardiac arrest are unknown how they clinically correlate. Literature from critical care demonstrates that the right ventricle dilates, exhibits RV dysfunction, and carries a worse prognosis then that of the left ventricle. Recent animal data suggests that RV dilatation does occur in a porcine induced cardiac arrest model. To date, no human assessment of RV function and size in the immediate post-arrest state exists, and clearly a need to study this is evident.
objectives and hypothesis Objectives To assess the right ventricular function and size in patients who are immediately post-arrest patients.
Hypothesis Our hypothesis is that right ventricular dysfunction and dilatation is prevalent in the patients who are in cardiac arrest and in the post-cardiac arrest patient population, irrespective of they etiology of their cardiac arrest.
- Conditions
- Right Ventricular Dysfunction, Cardiac Arrest
- Medical subject headings
- Ventricular Dysfunction, Right, Heart Arrest
What is being measured
The primary outcome is the main question the study is designed to answer.
Right ventricular dysfunction
Assessment of RV dysfunction in post cardiac arrest patients.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start6 Oct 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: Low enrollment numbers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Right Ventricular DysfunctionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- University of British Columbia, Queen's University, Kingston, Ontario
- Responsible party
- Principal investigator, Tomislav Jelic, University of Manitoba
- Investigators
- Tomislav Jelic, MD, Principal investigator, University of Manitoba, Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03309852
- Sponsor's protocol ID
- B2017:104
- Status last verified
- Aug 2025
- First submitted
- 10 Oct 2017
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Department Assessment of Right Ventricular Function and Size in the Post Cardiac Arrest Patient
- ClinicalTrials.gov ID
- NCT03309852
- Acronym / sponsor ID
- B2017:104
- Conditions
- Right Ventricular Dysfunction, Cardiac Arrest
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment numbers.
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- University of British Columbia, Queen's University, Kingston, Ontario
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Oct 2017 (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.
The right side of the heart of often overlooked in patients who are acutely unwell, as the main area of focus when performing echocardiography tends to be the left ventricle. The right ventricle can yield important diagnostic clues that can aid the clinician, particularly in cases where one may suspect elevated right sided pressures, such as those due to a pulmonary embolus. Although it is taught that a dilated right ventricle is associated in patients with pulmonary embolus, but in patients with spontaneous circulation. What is unknown is patients who sustain a cardiac arrest, does the same hold true. There is a paucity of literature surrounding the appearance of the right ventricle in the cardiac arrest patient acutely. This study aims to assess right ventricular size and function in the immediate post cardiac arrest phase.
Detailed description
The use of point of care ultrasound (PoCUS) has grown rapidly. The incorporation of PoCUS in the assessment of patients in shock and to identify a reversible etiology to a patients cardiac arrest is widely practiced and endorsed by several organizations. While often overlooked, the right ventricle (RV) plays a critical role and often can provide clues to the etiology of a patient who is in shock. The right ventricle is very unique, as its anatomic structure, and function are markedly different then the left ventricle. What is often assessed is the size of the right ventricle. If dilated, which is defined as being >0.6 times that of the left ventricle, this could be indicative of elevated right sided pressures. In the right clinical context this may be caused by an acute pulmonary embolus. While this particular finding may raise clinical suspicion of acute right ventricular strain, point of care ultrasound cannot safely rule out acute pulmonary embolism. Several publications demonstrate the use of thrombolytics if a dilated RV is seen on PoCUS. This applies in patients with cardiac function who have not sustained a cardiac arrest. But in those patients who do sustain a cardiac arrest, these patients fall into a black hole of PoCUS findings related to the right ventricle. The international liaison committee on resuscitation has urged caution due to the unknown PoCUS findings during cardiac arrest. If one were to presume a dilated RV in a setting of a patient who sustained cardiac arrest was due to a pulmonary embolus, thrombolytics would be indicated. However, exposing the patient to thrombolytics, which in themselves carry a hemorrhage risk of 20%, is not a benign decision. Thus PoCUS findings as they pertain to the RV, in patient who sustain a cardiac arrest are unknown how they clinically correlate. Literature from critical care demonstrates that the right ventricle dilates, exhibits RV dysfunction, and carries a worse prognosis then that of the left ventricle. Recent animal data suggests that RV dilatation does occur in a porcine induced cardiac arrest model. To date, no human assessment of RV function and size in the immediate post-arrest state exists, and clearly a need to study this is evident.
objectives and hypothesis Objectives To assess the right ventricular function and size in patients who are immediately post-arrest patients.
Hypothesis Our hypothesis is that right ventricular dysfunction and dilatation is prevalent in the patients who are in cardiac arrest and in the post-cardiac arrest patient population, irrespective of they etiology of their cardiac arrest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Post cardiac arrest patients.
Key inclusion criteria (1 listed)
- Any post cardiac arrest patient who achieves return of spontaneous circulation that can have their RV assessed with point of care echo cardiography within 1 hour of ROSC.
Key exclusion criteria (1 listed)
- Significant hemodynamic instability, pregnancy, incarcerated patients, age <18.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Right ventricular dysfunction
Time frame: 12 months
Assessment of RV dysfunction in post cardiac arrest patients.
Results and safety
The study was stopped early (reason given: Low enrollment numbers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
Tomislav Jelic, MD principal investigator
University of Manitoba, Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Right Ventricular Dysfunction and 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 1 inclusion and 1 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: stopped early, as of the sponsor's last update on 24 Aug 2025. 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 was stopped early (reason given: Low enrollment numbers.). Results are not available in the source record.
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?
Right ventricular dysfunction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Aug 2025.