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

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ClinicalTrials.gov Identifier: NCT03119571
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : August 8, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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.

Condition or disease Intervention/treatment Phase
Cardiac Arrest Due to Underlying Cardiac Condition Ventricular Fibrillation Cardiopulmonary Arrest With Successful Resuscitation Procedure: Initial CCL admission Diagnostic Test: Initial ICU admission Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 864 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 12, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: Initial CCL admission
Admission to the CCL to evaluate the coronary artery disease
Procedure: Initial CCL admission
Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions

Active Comparator: 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.
Diagnostic Test: Initial ICU admission
Evaluate for additional testing and/or procedures




Primary Outcome Measures :
  1. Survival to hospital discharge with mRS ≤ 3 [ Time Frame: Up to 3 weeks ]
    mRS score



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119571


Contacts
Contact: Demetris Yannopoulos, MD 6126261382 yanno001@umn.edu
Contact: Emily Caldwell, BSN caldw076@umn.edu

Locations
United States, Georgia
Grady Memorial Hospital Recruiting
Atlanta, Georgia, United States, 30303
Contact: Lekshmi Kumar, MD         
Contact: Alaina Williams       alaina.williams@emory.edu   
United States, Minnesota
North Memorial Medical Center Not yet recruiting
Brooklyn Center, Minnesota, United States, 55429
Contact: Marc Conterato, MD       marc.conterato@northmemorial.com   
Fairview Southdale Hospital Recruiting
Edina, Minnesota, United States, 55435
Contact: Gregory Helmer, MD         
Contact: Maggie Peterson, RN         
University of Minnesota Medical Center, Fairview Recruiting
Edina, Minnesota, United States, 55455
Contact: Demetris Yannopoulos, MD         
Contact: Emily Caldwell, RN         
Hennepin County Medical Center Recruiting
Minneapolis, Minnesota, United States, 55415
Contact: Louis Kohl, MD       louis.kohl@hcmed.org   
Contact: Shari Mackedanz, RN       shari.mackendanz@hcmed.org   
Methodist Hospital Recruiting
Saint Louis Park, Minnesota, United States, 55426
Contact: Ann Coumbe, MD         
Contact: Liz Ramey       elizabeth.s.ramey@healthpartners.com   
Regions Hospital Recruiting
Saint Paul, Minnesota, United States, 55101
Contact: Johannes Brechtken, MD         
Contact: Elizabeth Ramey       elizabeth.s.ramey@healthpartners.com   
St. Joseph's Hospital Recruiting
Saint Paul, Minnesota, United States, 55102
Contact: Carmello Panetta, MD         
Contact: Beth Jorgenson, RN       bjorgenson@healtheast.org   
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Clifton Callaway, MD         
Contact: Sara DiFiore       difioresm@upmc.edu   
United States, Texas
Parkland Memorial Hospital Not yet recruiting
Dallas, Texas, United States, 75235
Contact: Ahamed Idris, MD         
Contact: Dixie Climer    214-648-0408    dixie.climer@utsouthwestern.edu   
United States, Wisconsin
Medical College of Wisconsin Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Tom Aufderheide, MD       TAufderh@mcw.edu   
Contact: Melissa Mena       mmena@mcw.edu   
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
Investigators
Principal Investigator: Demetris Yannopoulos, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Tom Aufderheide, MD MCW

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03119571     History of Changes
Other Study ID Numbers: ACCESS Trial
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Cardiac arrest
Ventricular fibrillation
coronary artery disease

Additional relevant MeSH terms:
Heart Arrest
ST Elevation Myocardial Infarction
Ventricular Fibrillation
Heart Diseases
Cardiovascular Diseases
Myocardial Infarction
Myocardial Ischemia
Vascular Diseases
Arrhythmias, Cardiac
Pathologic Processes