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

NCT03119571 | Terminated Results DMC FDA Device

• 1 other identifier: CV-2017-25768
• Study Type: interventional
• Target: 65
• Locations: 2 countries
• Sites: 23

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.

Conditions

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

Keywords

Cardiac arrest; Ventricular fibrillation; coronary artery disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Initial CCL admission

EXPERIMENTAL

Admission to the CCL to evaluate the coronary artery disease

Procedure: Initial CCL admission

Initial ICU admission

ACTIVE COMPARATOR

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

Interventions

Initial CCL admission PROCEDURE

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

Initial CCL admission

Initial ICU admission DIAGNOSTIC_TEST

Evaluate for additional testing and/or procedures

Initial ICU admission

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (23)

Grady Memorial Hospital

Atlanta, Georgia, 30303, United States

Location

Indiana University Health Methodist Hospital

Indianapolis, Indiana, 46202, United States

Location

University Hospital

Ann Arbor, Michigan, 48109, United States

Location

St. Joseph Mercy Hospital

Ypsilanti, Michigan, 48197, United States

Location

North Memorial Medical Center

Brooklyn Center, Minnesota, 55429, United States

Location

Fairview Southdale Hospital

Edina, Minnesota, 55435, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

University of Minnesota Medical Center, Fairview

Minneapolis, Minnesota, 55455, United States

Location

Methodist Hospital

Saint Louis Park, Minnesota, 55426, United States

Location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

St. Joseph's Hospital

Saint Paul, Minnesota, 55102, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

Miriam Hospital

Providence, Rhode Island, 02903, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

Virginia Commonwealth University Hospital

Richmond, Virginia, 23298, United States

Location

Harborview Medical Center

Seattle, Washington, 98104, United States

Location

Medical College of Wisconsin Froedtert Hospital

Milwaukee, Wisconsin, 53226, United States

Location

St. Paul's Hospital

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V6Z 2K8, Canada

Location

MeSH Terms

Conditions

Ventricular Fibrillation; Heart Arrest; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Demetri Yannopoulos, MD
• Organization: University of Minnesota

yanno001@umn.edu

6126261382

Study Officials

• Demetris Yannopoulos, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• Tom Aufderheide, MD

  MCW

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2017
• First Posted: April 18, 2017
• Study Start: December 12, 2017
• Primary Completion: November 26, 2019
• Study Completion: November 26, 2019
• Last Updated: January 27, 2021
• Results First Posted: January 27, 2021

Record last verified: 2021-01

Locations

CA (2); US (21)