Clinical Trial: ACCESS to the Cardiac Catheterization Laboratory in Patients With NSTEMI Resuscitated From Out-of-hospital VT/VF Arrest

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: ACCESS to the Cardiac Catheterization Laboratory in Patients Without ST-segment Elevation Myocardial Infarction Resuscitated From Out-of-hospital Ventricular Fibrillation

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 Summary:

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.

mRS score



Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Minnesota - Clinical and Translational Science Institute

Dates:
Date Received: March 29, 2017
Date Started: January 2018
Date Completion: December 2021
Last Updated: April 13, 2017
Last Verified: April 2017