Immediate Unselected Coronary Angiography Versus Delayed Triage in Survivors of Out-of-hospital Cardiac Arrest Without ST-segment Elevation (TOMAHAWK)

University Hospital Schleswig-Holstein (UKSH)

Status and phase: Completed; Phase 4

Conditions: Out-of-hospital Cardiac Arrest

Treatments: Other: Delayed/selective coronary angiography; Other: Immediate coronary angiography

Study type: Interventional

Funder types: Other

Identifiers

NCT02750462

TOMAHAWK2.0

Details and patient eligibility

About

The aim of the trial is to compare immediate angiography in survivors of out of hospital cardiac arrest (OHCA) without ST-segment elevation versus delayed/selective catheterization with respect to 30 day mortality.

The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

Full description

After inclusion and exclusion criteria have been checked patients will be randomized:

Group 1: Immediate angiography Patients randomized to group 1 will be transported to the catheterization laboratory as soon as possible after hospital admission for evaluation of coronary anatomy.

Group 2: Delayed/selective angiography Upon hospital admission, patients assigned to group 2 will first be transported to the ICU for further evaluation and stratification of OHCA etiology. Further triage will depend on the results of clinical examination and objective testing and will be left to the individual physician according to clinical judgment. Depending on clinical circumstances, further management may comprise medical therapy, laboratory testing, imaging such as echocardiography and/or computed tomography, hemodynamic or neurological monitoring, the initiation of therapeutic hypothermia or other measures of intensive care. If a high likelihood of an acute coronary trigger for OHCA persists (i.e. inconclusive results from clinical evaluation with ongoing suspicion of an acute coronary event, etc.), the treating physician may proceed to coronary angiography after a delay of 24h after the onset of cardiac arrest.

Vital status will be assessed at 30 days, 6 and 12 months after randomization by direct questioning if the patient is still hospitalized or structured telephone interview. Clinical events will be verified by original source data. At 6 and 12 months, quality of life will be assessed by the the Euroqol 5D questionnaire.

The TOMAHAWK trial is supported by the Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK).

Enrollment: 558 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Documented resuscitated OHCA of possible cardiac origin and return of spontaneous circulation
• Age ≥30 years
• Informed consent

Exclusion criteria

• ST-segment elevation or new left bundle branch block
• No return of spontaneous circulation upon hospital admission
• Severe hemodynamic or electrical instability requiring immediate coronary angiography/intervention (delay clinically not acceptable)
• Obvious extra-cardiac etiology such as traumatic brain injury, primary metabolic or electrolyte disorders, intoxication, overt hemorrhage, respiratory failure due to known lung disease, suffocation, drowning
• In-hospital cardiac arrest
• Known or likely pregnancy
• Participation in another intervention study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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558 participants in 2 patient groups

Immediate coronary angiography

Experimental group

Description:

Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation

Treatment:

Other: Immediate coronary angiography

Delayed/selective coronary angiography

Active Comparator group

Description:

Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated

Treatment:

Other: Delayed/selective coronary angiography