ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest

Primary Aim

Determine survival to hospital discharge with Modified Rankin Scale Score (mRS) ≤ 3 in adult
(18-75 years old) patients resuscitated from out-of-hospital VT/VF cardiac arrest who do not
have ST-segment elevation on emergency department 12-lead ECG (no-STEMI) randomized to
receive either: 1) initial CCL admission, or 2) initial ICU admission.

Hypothesis: The corresponding hypothesis is that a large proportion of all resuscitated
patients presenting with VT/VF have ischemic heart disease as the underlying cause for the
participants cardiac arrest and that a strategy to facilitate prompt revascularization in all
patients presenting with VT/VF who do not have ST-segment elevation on emergency department
12-lead ECG will improve survival with good neurological outcome.

Primary Endpoint

Survival to hospital discharge with mRS ≤ 3

Secondary Aims

Determine secondary assessments of survival, left ventricular function, hospital duration,
and rehabilitation in-hospital and assessment of survival and functional status at 3 months
in both groups.

Hypothesis: The corresponding hypothesis is that initial CCL admission will result in
improved secondary assessment values at 3 months.

Secondary Endpoints

In-hospital secondary endpoints: Survival to hospital discharge, CPC score, mean peak
troponin level, mean ejection fraction, mean length of ICU stay, mean hospitalization
duration, the incidence of and mean length of rehabilitation.

3-month post-hospital discharge secondary endpoint: Survival to 3 months, survival to 3
months with mRS ≤ 3, functional status at 3 months (CPC score), incidence and length of
rehabilitation, incidence of congestive heart failure, incidence of re-hospitalization over 3
months, and incidence and time to return to work.

Pragmatic Clinical Trial

The ACCESS Trial will randomize patients to receive one of two standard treatments currently
practiced in the United States: either, 1) initial CCL admission, or 2) initial ICU
admission. Other than randomizing to one of these two standard treatments, care is not
otherwise specified and is completely at the discretion of the treating clinician, including
coronary interventions, if any, hemodynamic support, medications, therapeutic hypothermia,
and all other interventions and clinical care.

Inclusion Criteria:

- Adult presumed or known to be 18-75 years old

- Resuscitated from OOHCA

- Initial cardiac arrest rhythm of pulseless VT/VF (including patients treated with an
AED)

- No ST-segment elevation MI (No STEMI) (or STEMI-equivalent syndrome) on ED 12-lead ECG
(as interpreted by a physician)

Exclusion Criteria:

- Initial non-shockable out-of-hospital cardiac arrest rhythm (pulseless electrical
activity or asystole)

- Valid do not resuscitate orders (DNR),

- Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose,

- Known prisoners

- Known pregnancy,

- ST-segment elevation on ED 12-lead ECG (as interpreted by a physician)

- Absolute contraindications to emergent coronary angiography including,

- known anaphylactic reaction to angiographic contrast media,

- active gastrointestinal or internal bleeding, or

- severe concomitant illness that drastically shortens life expectancy or increases risk
of the procedure.

- Suspected or confirmed intracranial bleeding

- Refractory cardiac arrest (prior to randomization)

- Patients meeting ACCESS Trial eligibility criteria initially seen in an outside
hospital and then transferred to an ACCESS Trial participating hospital