Out of Hospital Cardiac ArrestNCT02587494
Cardiac Catheterization in Cardiac Arrest
A study testing Cardiac catheterization in people with Out of Hospital Cardiac Arrest, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Out of Hospital Cardiac Arrest
- What is being tested?
- Cardiac catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2017to Dec 2018
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.
- Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes
Who cannot join
- ST-elevation on any of the ECGs post resuscitation
- Hypothermia <30°C
- Interval from ROSC to screening of >12h
- Suspected or known acute intracranial hemorrhage or stroke
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Centre
London, Ontario, N6A5A5
Shahar Lavi, MD, 519-663-3611, shahar.lavi@lhsc.on.ca
Mistre Alemayehu, MSc, 519-685-8500 ext. 35625, mistre.alemayehu@lhsc.on.ca
About this study
Official title: Role of Early Cardiac Catheterization in Cardiac Arrest
This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.
Read the detailed description
A pilot multicenter RCT.
The objectives of the study are:
To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.
Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care
- Conditions
- Out of Hospital Cardiac Arrest
- Being tested
- Cardiac catheterization
- Medical subject headings
- Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac catheterizationProcedure or surgery
Also called Coronary angiography
Cardiac catheterization / coronary angiography is a diagnostic procedure used to define the coronary anatomy and presence of obstructive coronary lesions or culprit lesions. According to the findings, it may lead to percutaneous coronary intervention (PCI) using stents
| Study group | Role | What they receive |
|---|---|---|
| Early cardiac catheterization | Active comparator | Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia Receives: Procedure: Cardiac catheterization |
| Medical arm | No intervention | Initial therapy does not include cardiac catheterization. Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for >24h post ROSC. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
Measured: 30 days
Secondary outcomes (10)
Death
Measured: 30 day
CPC score
Measured: up to 30 days
Acute kidney injury- creatinine levels
Number of participants with increase in serum creatinine of ≥44.2 μmol/L, or a 25% relative rise in creatinine, within 48 h after contrast exposure42
Measured: 48 hours
Myocardial infarction - according to cardiac troponin levels
Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction.
Measured: 30 days
Stent thrombosis by pathology or angiography
Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria
Measured: 30 days
Bleeding - according to Hb levels
Number of participant with overt bleeding according to Academic Research Consortium criteria
Measured: 30 days
Composite of death and poor neurologic outcome
Measured: 1 year
Stroke - imaging or pathology
New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)
Measured: 30 days
Heart failure (NYHA 3-4)
Measured: 30 days
Estimated cost per patient according to length of stay and procedures performed
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startDec 2017 (estimated)
- Primary completionDec 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Out of Hospital Cardiac ArrestStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shahar Lavi, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Shahar Lavi, MD, Principal investigator, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02587494
- Sponsor's protocol ID
- 106834
- Status last verified
- Aug 2017
- First submitted
- 27 Aug 2015
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Early Cardiac Catheterization in Cardiac Arrest
- ClinicalTrials.gov ID
- NCT02587494
- Acronym / sponsor ID
- 106834
- Conditions
- Out of Hospital Cardiac Arrest
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Dec 2017 (estimated)
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Oct 2015 (estimated)
- 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.
This is a pilot study that will lead to a large randomized control trial (RCT), to assess whether early versus late or no cardiac catheterization is associated with improved outcomes in out-of-hospital cardiac arrest (OHCA) patients.
Detailed description
A pilot multicenter RCT.
The objectives of the study are:
To assess whether early (within 12 hours) cardiac catheterization is associated with improved survival, neurologic and cardiovascular outcomes in OHCA patients.
Patients will be randomized 1:1 to early cardiac catheterization, performed as early as possible, within 12h post return of spontaneous circulation (ROSC) following OHCA, or to standard practice, which may include medical management without cardiac catheterization or late cardiac catheterization after completion of therapeutic hypothermia. Percutaneous coronary intervention (PCI) is recommended for culprit lesions found on diagnostic angiography. All patients will undergo therapeutic hypothermia started as soon as possible with target temperature below 36°C according to local practice. Other medical management will be according to standard of care
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early cardiac catheterization | Active comparator | Procedure: Cardiac catheterizationCardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia |
| Medical arm | No intervention | –Initial therapy does not include cardiac catheterization. Cardiac catheterization with possible PCI is allowed after completion of mild therapeutic hypothermia or apyrexia for >24h post ROSC. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Glasgow Coma Scale score <8 on hospital admission following OHCA of presumed cardiac cause.
- Initial rhythm ventricular tachycardia (VT) / ventricular fibrillation (VF), who achieved ROSC sustained for >20 consecutive minutes
Key exclusion criteria (4 listed)
- ST-elevation on any of the ECGs post resuscitation
- Hypothermia <30°C
- Interval from ROSC to screening of >12h
- Suspected or known acute intracranial hemorrhage or stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac catheterizationAlso: Coronary angiographyCardiac catheterization / coronary angiography is a diagnostic procedure used to define the coronary anatomy and presence of obstructive coronary lesions or culprit lesions. According to the findings, it may lead to percutaneous coronary intervention (PCI) using stents | Procedure or surgery | Early cardiac catheterization |
Primary outcome
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
Time frame: 30 days
10 secondary outcomes
Death
Time frame: 30 day
CPC score
Time frame: up to 30 days
Acute kidney injury- creatinine levels
Time frame: 48 hours
Myocardial infarction - according to cardiac troponin levels
Time frame: 30 days
Stent thrombosis by pathology or angiography
Time frame: 30 days
Bleeding - according to Hb levels
Time frame: 30 days
Composite of death and poor neurologic outcome
Time frame: 1 year
Stroke - imaging or pathology
Time frame: 30 days
Heart failure (NYHA 3-4)
Time frame: 30 days
Estimated cost per patient according to length of stay and procedures performed
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
Related trials for Out of Hospital Cardiac Arrest
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
RecruitingObservational study
Cardiac Arrest - Ultrasound Detection of Occult Perfusion
Cardiac Arrest, Out-Of-Hospital, Hypotension
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
Active, not recruitingObservational study
Psychoactive Drug Use and Acute Care Use After Trauma and Out-of-Hospital Cardiac Arrest
Wounds and Injuries, Out-of-Hospital Cardiac Arrest
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.
Shahar Lavi, MD principal investigator
London Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac catheterization in people with Out of Hospital Cardiac Arrest, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's 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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 23 Aug 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shahar Lavi, MD (519-6633611, shahar.lavi@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5). (time frame: 30 days). 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 23 Aug 2017; AzTrials last refreshed its copy on 30 Oct 2026.