Cardiac Catheterization in Cardiac Arrest

Lawson Health Research Institute

Status: Unknown

Conditions: Out of Hospital Cardiac Arrest

Treatments: Procedure: Cardiac catheterization

Study type: Interventional

Funder types: Other

Identifiers

NCT02587494

106834

Details and patient eligibility

About

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.

Full 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

Enrollment: 75 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Early cardiac catheterization

Active Comparator group

Description:

Cardiac catheterization performed as early as possible, within 12h post ROSC following OHCA, with possible PCI during mild therapeutic hypothermia or apyrexia

Treatment:

Procedure: Cardiac catheterization

Medical arm

No Intervention group

Description:

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.