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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 : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : August 12, 2019
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

Tracking Information
First Submitted Date  ICMJE March 29, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date August 12, 2019
Actual Study Start Date  ICMJE December 12, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
Survival to hospital discharge with mRS ≤ 3 [ Time Frame: Up to 3 weeks ]
mRS score
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03119571 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest
Official Title  ICMJE ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation Cardiac Arrest
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cardiac Arrest Due to Underlying Cardiac Condition
  • Ventricular Fibrillation
  • Cardiopulmonary Arrest With Successful Resuscitation
Intervention  ICMJE
  • Procedure: Initial CCL admission
    Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions
  • Diagnostic Test: Initial ICU admission
    Evaluate for additional testing and/or procedures
Study Arms  ICMJE
  • Experimental: Initial CCL admission
    Admission to the CCL to evaluate the coronary artery disease
    Intervention: Procedure: Initial CCL admission
  • 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.
    Intervention: Diagnostic Test: Initial ICU admission
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
864
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03119571
Other Study ID Numbers  ICMJE ACCESS Trial
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party University of Minnesota - Clinical and Translational Science Institute
Study Sponsor  ICMJE University of Minnesota - Clinical and Translational Science Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Demetris Yannopoulos, MD University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Tom Aufderheide, MD MCW
PRS Account University of Minnesota - Clinical and Translational Science Institute
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP