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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
75
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
London Health Sciences Centre
London, Ontario, Canada
Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
Time frame: 30 days
Death
Time frame: 30 day
CPC score
Time frame: 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
Time frame: 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.
Time frame: 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
Time frame: 30 days
Bleeding - according to Hb levels
Number of participant with overt bleeding according to Academic Research Consortium criteria
Time frame: 30 days
Composite of death and poor neurologic outcome
Time frame: 1 year
Stroke - imaging or pathology
New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging)
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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