Clinical trial NCT03119571: ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiac Arrest Due to Underlying Cardiac Condition
Ventricular Fibrillation
Cardiopulmonary Arrest With Successful Resuscitation
Keywords: Cardiac arrest
Ventricular fibrillation
coronary artery disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2017-04-18
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Survival to Hospital Discharge With mRS ≤ 3
timeFrame: Up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Health Methodist Hospital
state: Indiana
city: Ann Arbor
country: United States
facility: University Hospital
state: Michigan
city: Ypsilanti
country: United States
facility: St. Joseph Mercy Hospital
state: Michigan
city: Brooklyn Center
country: United States
facility: North Memorial Medical Center
state: Minnesota
city: Edina
country: United States
facility: Fairview Southdale Hospital
state: Minnesota
city: Minneapolis
country: United States
facility: Hennepin County Medical Center
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center, Fairview
state: Minnesota
city: Saint Louis Park
country: United States
facility: Methodist Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Saint Paul
country: United States
facility: St. Joseph's Hospital
state: Minnesota
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Pittsburgh
country: United States
facility: Allegheny General Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Providence
country: United States
facility: Miriam Hospital
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: Virginia Commonwealth University Hospital
state: Virginia
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin Froedtert Hospital
state: Wisconsin
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
Study officials:
affiliation: University of Minnesota
name: Demetris Yannopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MCW
name: Tom Aufderheide, MD
role: PRINCIPAL_INVESTIGATOR
References: