Out of Hospital Cardiac Arrest
Conditions
Brief 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.
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
Interventions
PROCEDURECardiac catheterization
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
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5). | 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 30 day | — |
| CPC score | up to 30 days | — |
| Acute kidney injury- creatinine levels | 48 hours | 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 |
| Myocardial infarction - according to cardiac troponin levels | 30 days | Number of participants with myocardial infarction post percutaneous coronary interventions, in accordance with the universal definition of myocardial infarction. |
| Estimated cost per patient according to length of stay and procedures performed | 30 days | — |
| Bleeding - according to Hb levels | 30 days | Number of participant with overt bleeding according to Academic Research Consortium criteria |
| Composite of death and poor neurologic outcome | 1 year | — |
| Stroke - imaging or pathology | 30 days | New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging) |
| Heart failure (NYHA 3-4) | 30 days | — |
| Stent thrombosis by pathology or angiography | 30 days | Number of participants with definite stent thrombosis confirmed by angiography or pathology according to the Academic research consortium criteria |
Countries
Canada
Contacts
Primary ContactShahar Lavi, MD
Backup ContactMistre Alemayehu
Outcome results
None listed