Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac catheterization | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5). | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Death | 30 day | |
| CPC score | up to 30 days | |
| Acute kidney injury- creatinine levels |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Shahar Lavi, MD | Contact | 519-6633611 | shahar.lavi@lhsc.on.ca | |
| Mistre Alemayehu | Contact | 519-6633611 | mistre.alemayehu@lhsc.on.ca |
| Name | Affiliation | Role |
|---|---|---|
| Shahar Lavi, MD | London Health Sciences Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | N6A5A5 | Canada |
Not provided
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006328 | Cardiac Catheterization |
| ID | Term |
|---|---|
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
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
| 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. | 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 | 30 days |
| Bleeding - according to Hb levels | Number of participant with overt bleeding according to Academic Research Consortium criteria | 30 days |
| Composite of death and poor neurologic outcome | 1 year |
| Stroke - imaging or pathology | New stroke following hypothermia confirmed by imaging (computer tomography or magnetic resonance imaging) | 30 days |
| Heart failure (NYHA 3-4) | 30 days |
| Estimated cost per patient according to length of stay and procedures performed | 30 days |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |