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

Primary Purpose

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

Status
Terminated
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Initial CCL admission
Initial ICU admission
Sponsored by
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Arrest Due to Underlying Cardiac Condition focused on measuring Cardiac arrest, Ventricular fibrillation, coronary artery disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grady Memorial Hospital
  • Indiana University Health Methodist Hospital
  • University Hospital
  • St. Joseph Mercy Hospital
  • North Memorial Medical Center
  • Fairview Southdale Hospital
  • Hennepin County Medical Center
  • University of Minnesota Medical Center, Fairview
  • Methodist Hospital
  • Regions Hospital
  • St. Joseph's Hospital
  • University of Cincinnati
  • Allegheny General Hospital
  • University of Pittsburgh
  • Miriam Hospital
  • Rhode Island Hospital
  • Parkland Memorial Hospital
  • University of Utah
  • Virginia Commonwealth University Hospital
  • Harborview Medical Center
  • Medical College of Wisconsin Froedtert Hospital
  • St. Paul's Hospital
  • Vancouver General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Initial CCL admission

Initial ICU admission

Arm Description

Admission to the CCL to evaluate the coronary artery disease

Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
March 29, 2017
Last Updated
January 8, 2021
Sponsor
University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT03119571
Brief Title
ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest
Official Title
ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation Cardiac Arrest
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment, funding withdrawn
Study Start Date
December 12, 2017 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Arrest Due to Underlying Cardiac Condition, Ventricular Fibrillation, Cardiopulmonary Arrest With Successful Resuscitation
Keywords
Cardiac arrest, Ventricular fibrillation, coronary artery disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Initial CCL admission
Arm Type
Experimental
Arm Description
Admission to the CCL to evaluate the coronary artery disease
Arm Title
Initial ICU admission
Arm Type
Active Comparator
Arm Description
Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team.
Intervention Type
Procedure
Intervention Name(s)
Initial CCL admission
Intervention Description
Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions
Intervention Type
Diagnostic Test
Intervention Name(s)
Initial ICU admission
Intervention Description
Evaluate for additional testing and/or procedures
Primary Outcome Measure Information:
Title
Survival to Hospital Discharge With mRS ≤ 3
Description
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.
Time Frame
Up to 3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Demetris Yannopoulos, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tom Aufderheide, MD
Organizational Affiliation
MCW
Official's Role
Principal Investigator
Facility Information:
Facility Name
Grady Memorial Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Indiana University Health Methodist Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
University Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
St. Joseph Mercy Hospital
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
North Memorial Medical Center
City
Brooklyn Center
State/Province
Minnesota
ZIP/Postal Code
55429
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Hennepin County Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
University of Minnesota Medical Center, Fairview
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Methodist Hospital
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55426
Country
United States
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15261
Country
United States
Facility Name
Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Virginia Commonwealth University Hospital
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Medical College of Wisconsin Froedtert Hospital
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 2K8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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