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Recruitment Status : Terminated (Low enrollment, funding withdrawn)
First Posted : April 18, 2017
Results First Posted : January 27, 2021
Last Update Posted : January 27, 2021
|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|
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.
Survival to hospital discharge with mRS ≤ 3
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.
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)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Primary Completion Date :||November 26, 2019|
|Actual Study Completion Date :||November 26, 2019|
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
- Survival to Hospital Discharge With mRS ≤ 3 [ Time Frame: Up to 3 weeks ]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.
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
|Principal Investigator:||Demetris Yannopoulos, MD||University of Minnesota|
|Principal Investigator:||Tom Aufderheide, MD||MCW|