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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03119571
Other study ID # CV-2017-25768
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date December 12, 2017
Est. completion date November 26, 2019

Study information

Verified date January 2021
Source University of Minnesota
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 65
Est. completion date November 26, 2019
Est. primary completion date November 26, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada St. Paul's Hospital Vancouver British Columbia
Canada Vancouver General Hospital Vancouver British Columbia
United States University Hospital Ann Arbor Michigan
United States Grady Memorial Hospital Atlanta Georgia
United States North Memorial Medical Center Brooklyn Center Minnesota
United States University of Cincinnati Cincinnati Ohio
United States Parkland Memorial Hospital Dallas Texas
United States Fairview Southdale Hospital Edina Minnesota
United States Indiana University Health Methodist Hospital Indianapolis Indiana
United States Medical College of Wisconsin Froedtert Hospital Milwaukee Wisconsin
United States Hennepin County Medical Center Minneapolis Minnesota
United States University of Minnesota Medical Center, Fairview Minneapolis Minnesota
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 Virginia Commonwealth University Hospital Richmond Virginia
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 Utah Salt Lake City Utah
United States Harborview Medical Center Seattle Washington
United States St. Joseph Mercy Hospital Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
University of Minnesota

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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