ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03119571|
Recruitment Status : Recruiting
First Posted : April 18, 2017
Last Update Posted : March 23, 2018
|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)|
|Estimated Enrollment :||864 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|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||December 2021|
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 ]mRS score
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
|Contact: Demetris Yannopoulos, MDemail@example.com|
|Contact: Emily Caldwell, BSNfirstname.lastname@example.org|
|United States, Minnesota|
|North Memorial Medical Center||Not yet recruiting|
|Brooklyn Center, Minnesota, United States, 55429|
|Contact: Marc Conterato, MD email@example.com|
|Fairview Southdale Hospital||Recruiting|
|Edina, Minnesota, United States, 55435|
|Contact: Gregory Helmer, MD|
|Contact: Maggie Peterson, RN|
|University of Minnesota Medical Center, Fairview||Recruiting|
|Edina, Minnesota, United States, 55455|
|Contact: Demetris Yannopoulos, MD|
|Contact: Emily Caldwell, RN|
|Hennepin County Medical Center||Recruiting|
|Minneapolis, Minnesota, United States, 55415|
|Contact: Louis Kohl, MD firstname.lastname@example.org|
|Contact: Shari Mackedanz, RN email@example.com|
|Saint Paul, Minnesota, United States, 55101|
|Contact: Johannes Brechtken, MD|
|Contact: Elizabeth Ramey firstname.lastname@example.org|
|St. Joseph's Hospital||Recruiting|
|Saint Paul, Minnesota, United States, 55102|
|Contact: Carmello Panetta, MD|
|Contact: Beth Jorgenson, RN email@example.com|
|United States, Pennsylvania|
|University of Pittsburgh||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15261|
|Contact: Clifton Callaway, MD|
|Contact: Sara DiFiore firstname.lastname@example.org|
|United States, Wisconsin|
|Medical College of Wisconsin Froedtert Hospital||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Contact: Tom Aufderheide, MD TAufderh@mcw.edu|
|Contact: Melissa Mena email@example.com|
|Principal Investigator:||Demetris Yannopoulos, MD||University of Minnesota - Clinical and Translational Science Institute|
|Principal Investigator:||Tom Aufderheide, MD||MCW|