ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest

Ventricular Fibrillation Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03119571
• Other study ID #: CV-2017-25768
• Status: Terminated
• Phase: N/A
• 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
• 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest Due to Underlying Cardiac Condition
• Cardiopulmonary Arrest With Successful Resuscitation
• Heart Arrest
• Ventricular Fibrillation

Intervention

Procedure:
• Initial CCL admission
Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions

Diagnostic Test:
• Initial ICU admission
Evaluate for additional testing and/or procedures

Locations

Country	Name	City	State
Canada	St. Paul's Hospital	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
United States	University Hospital	Ann Arbor	Michigan
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	North Memorial Medical Center	Brooklyn Center	Minnesota
United States	University of Cincinnati	Cincinnati	Ohio
United States	Parkland Memorial Hospital	Dallas	Texas
United States	Fairview Southdale Hospital	Edina	Minnesota
United States	Indiana University Health Methodist Hospital	Indianapolis	Indiana
United States	Medical College of Wisconsin Froedtert Hospital	Milwaukee	Wisconsin
United States	Hennepin County Medical Center	Minneapolis	Minnesota
United States	University of Minnesota Medical Center, Fairview	Minneapolis	Minnesota
United States	Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Miriam Hospital	Providence	Rhode Island
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Virginia Commonwealth University Hospital	Richmond	Virginia
United States	Methodist Hospital	Saint Louis Park	Minnesota
United States	Regions Hospital	Saint Paul	Minnesota
United States	St. Joseph's Hospital	Saint Paul	Minnesota
United States	University of Utah	Salt Lake City	Utah
United States	Harborview Medical Center	Seattle	Washington
United States	St. Joseph Mercy Hospital	Ypsilanti	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Survival to Hospital Discharge With mRS = 3	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.	Up to 3 weeks