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

NCT ID: NCT03119571

Last Updated: 2021-01-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-12
• Study Completion Date: 2019-11-26

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Initial CCL admission

Admission to the CCL to evaluate the coronary artery disease

Group Type: EXPERIMENTAL

Initial CCL admission

Intervention Type: PROCEDURE

Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions

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.

Group Type: ACTIVE_COMPARATOR

Initial ICU admission

Intervention Type: DIAGNOSTIC_TEST

Evaluate for additional testing and/or procedures

Interventions

Initial CCL admission

Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions

Intervention Type: PROCEDURE

Initial ICU admission

Evaluate for additional testing and/or procedures

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Demetris Yannopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Tom Aufderheide, MD

Role: PRINCIPAL_INVESTIGATOR

MCW

Locations

Grady Memorial Hospital

Atlanta, Georgia, United States

Indiana University Health Methodist Hospital

Indianapolis, Indiana, United States

University Hospital

Ann Arbor, Michigan, United States

St. Joseph Mercy Hospital

Ypsilanti, Michigan, United States

North Memorial Medical Center

Brooklyn Center, Minnesota, United States

Fairview Southdale Hospital

Edina, Minnesota, United States

Hennepin County Medical Center

Minneapolis, Minnesota, United States

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, United States

Methodist Hospital

Saint Louis Park, Minnesota, United States

Regions Hospital

Saint Paul, Minnesota, United States

St. Joseph's Hospital

Saint Paul, Minnesota, United States

University of Cincinnati

Cincinnati, Ohio, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Miriam Hospital

Providence, Rhode Island, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Parkland Memorial Hospital

Dallas, Texas, United States

University of Utah

Salt Lake City, Utah, United States

Virginia Commonwealth University Hospital

Richmond, Virginia, United States

Harborview Medical Center

Seattle, Washington, United States

Medical College of Wisconsin Froedtert Hospital

Milwaukee, Wisconsin, United States

St. Paul's Hospital

Vancouver, British Columbia, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form: Main Consent

View Document

Document Type: Informed Consent Form: Continued Participation Consent

View Document

Other Identifiers

CV-2017-25768

Identifier Type: -

Identifier Source: org_study_id