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

Not Applicable

Terminated

• Conditions: Cardiac Arrest Due to Underlying Cardiac Condition; Cardiopulmonary Arrest With Successful Resuscitation; Ventricular Fibrillation
• Interventions: Diagnostic Test: Initial ICU admission; Procedure: Initial CCL admission

• Registration Number: NCT03119571
• Lead Sponsor: University of Minnesota

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

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.

Study Timeline

• Study First Submitted: 2017-03-29
• Study First Submitted QC: 2017-04-13
• Study First Posted: 2017-04-18
• Study Start: 2017-12-12
• Primary Completion: 2019-11-26
• Study Completion: 2019-11-26
• Results First Submitted: 2020-11-25
• Status Verified: 2021-01
• Results First Submitted QC: 2021-01-08
• Last Update Submitted: 2021-01-08
• Results First Posted: 2021-01-27
• Last Update Posted: 2021-01-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 65

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Initial ICU admission	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.
Initial CCL admission	Initial CCL admission	Admission to the CCL to evaluate the coronary artery disease

Primary Outcome Measures

Name	Time	Method
Survival to Hospital Discharge With mRS ≤ 3	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.

Trial Locations

Locations (23)

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

University of Minnesota Medical Center, Fairview; 🇺🇸 Minneapolis, Minnesota, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States

Virginia Commonwealth University Hospital; 🇺🇸 Richmond, Virginia, United States

Fairview Southdale Hospital; 🇺🇸 Edina, Minnesota, United States

North Memorial Medical Center; 🇺🇸 Brooklyn Center, Minnesota, United States

St. Joseph Mercy Hospital; 🇺🇸 Ypsilanti, Michigan, United States

Miriam Hospital; 🇺🇸 Providence, Rhode Island, United States

Regions Hospital; 🇺🇸 Saint Paul, Minnesota, United States

Methodist Hospital; 🇺🇸 Saint Louis Park, Minnesota, United States

Indiana University Health Methodist Hospital; 🇺🇸 Indianapolis, Indiana, United States

Grady Memorial Hospital; 🇺🇸 Atlanta, Georgia, United States

St. Joseph's Hospital; 🇺🇸 Saint Paul, Minnesota, United States

University of Cincinnati; 🇺🇸 Cincinnati, Ohio, United States

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States

St. Paul's Hospital; 🇨🇦 Vancouver, British Columbia, Canada

Parkland Memorial Hospital; 🇺🇸 Dallas, Texas, United States

University Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Medical College of Wisconsin Froedtert Hospital; 🇺🇸 Milwaukee, Wisconsin, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States