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.
