ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation Cardiac Arrest
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Minnesota
- Enrollment
- 65
- Locations
- 23
- Primary Endpoint
- Survival to Hospital Discharge With mRS ≤ 3
Study Overview
Brief Summary
To determine if survival to hospital discharge with good neurological outcome for adults ages 18-75 who are resuscitated from out-of-hospital VT/VF cardiac arrest without clinical signs of a heart attack do better by going straight to the cardiac catheterization laboratory or admitted to the intensive care unit for evaluation. The investigators think a large portion of resuscitated patients presenting with VT/VF have ischemic heart disease which is the cause for the arrest. And prompt access to the cardiac catheterization laboratory to reverse the blocked artery will improve survival with good neurological outcomes.
Detailed Description
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Initial CCL admission
Admission to the CCL to evaluate the coronary artery disease
Intervention: Initial CCL admission (Procedure)
Initial ICU admission
Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team.
Intervention: Initial ICU admission (Diagnostic Test)
Outcomes
Primary Outcomes
Survival to Hospital Discharge With mRS ≤ 3
Time Frame: Up to 3 weeks
Outcome is reported as the percent of participants who survive to hospital discharge with an mRS score less than or equal to 3. The Modified Rankin Score (mRS) is a 6-point scale measuring disability. Scores range from 0 (no disability) to 5 (severe disability; bedridden, incontinent, requires continuous care). Higher scores indicate greater disability. A sixth category is often added for patients who expire.
Secondary Outcomes
No secondary outcomes reported