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

Study Overview
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Brief Summary
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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
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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.

Official Title
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ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation Cardiac Arrest

Conditions
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Cardiac Arrest Due to Underlying Cardiac Condition, Ventricular Fibrillation, Cardiopulmonary Arrest With Successful Resuscitation

Intervention / Treatment
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* Procedure: Initial CCL admission
* Diagnostic Test: Initial ICU admission


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Initial CCL admission<br>Admission to the CCL to evaluate the coronary artery disease | Procedure: Initial CCL admission<br>* Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions<br>|
| Active Comparator: Initial ICU admission<br>Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team. | Diagnostic Test: Initial ICU admission<br>* Evaluate for additional testing and/or procedures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival to Hospital Discharge With mRS ≤ 3 | 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. | Up to 3 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cardiac arrest, Ventricular fibrillation, coronary artery disease