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Completed

NCT Number: NCT02750462

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

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).

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Universitäres Herzzentrum Lübeck

Lübeck, Schleswig-Holstein, 23538, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate coronary angiography

Other

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

Delayed/selective coronary angiography

Other

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

Primary outcomes

  1. All-cause mortality

    Time frame: 30 days

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Collaborators

  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

Registry information

Acronym: TOMAHAWK

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Apr 25, 2016
Registry last updated
Oct 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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