Clinical trial NCT02587494: Cardiac Catheterization in Cardiac Arrest
Official title: Role of Early Cardiac Catheterization in Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Out of Hospital Cardiac Arrest
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Composite of death and poor neurologic outcomes ( Cerebral Performance Category [CPC] score 3-5).
timeFrame: 30 days
Secondary outcomes:
measure: Death
timeFrame: 30 day
measure: CPC score
timeFrame: up to 30 days
measure: Acute kidney injury- creatinine levels
timeFrame: 48 hours
measure: Myocardial infarction - according to cardiac troponin levels
timeFrame: 30 days
measure: Stent thrombosis by pathology or angiography
timeFrame: 30 days
measure: Bleeding - according to Hb levels
timeFrame: 30 days
measure: Composite of death and poor neurologic outcome
timeFrame: 1 year
measure: Stroke - imaging or pathology
timeFrame: 30 days
measure: Heart failure (NYHA 3-4)
timeFrame: 30 days
measure: Estimated cost per patient according to length of stay and procedures performed
timeFrame: 30 days
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Shahar Lavi, MD
role: PRINCIPAL_INVESTIGATOR
References: