Cardiac Arrest Due to Underlying Cardiac ConditionNCT03119571
ACCESS to the Cardiac Cath Lab in Patients Without STEMI Resuscitated From Out-of-hospital VT/VF Cardiac Arrest
A study testing Initial CCL admission and Initial ICU admission in people with Cardiac Arrest Due to Underlying Cardiac Condition and Ventricular Fibrillation, run by University of Minnesota at 23 sites in 2 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrest Due to Underlying Cardiac Condition, Ventricular Fibrillation, Cardiopulmonary Arrest With Successful Resuscitation
- What is being tested?
- Initial CCL admission and Initial ICU admission
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 12 Dec 2017to 26 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Show all 13Show fewer
- 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
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States21 sites
University Hospital
Ann Arbor, Michigan, 48109
Grady Memorial Hospital
Atlanta, Georgia, 30303
North Memorial Medical Center
Brooklyn Center, Minnesota, 55429
University of Cincinnati
Cincinnati, Ohio, 45267
Parkland Memorial Hospital
Dallas, Texas, 75235
Fairview Southdale Hospital
Edina, Minnesota, 55435
Indiana University Health Methodist Hospital
Indianapolis, Indiana, 46202
Medical College of Wisconsin Froedtert Hospital
Milwaukee, Wisconsin, 53226
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
University of Pittsburgh
Pittsburgh, Pennsylvania, 15261
Miriam Hospital
Providence, Rhode Island, 02903
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University Hospital
Richmond, Virginia, 23298
Methodist Hospital
Saint Louis Park, Minnesota, 55426
Regions Hospital
Saint Paul, Minnesota, 55101
St. Joseph's Hospital
Saint Paul, Minnesota, 55102
University of Utah
Salt Lake City, Utah, 84132
Harborview Medical Center
Seattle, Washington, 98104
St. Joseph Mercy Hospital
Ypsilanti, Michigan, 48197
Canada2 sites
St. Paul's Hospital
Vancouver, British Columbia, V6Z 1Y6
Vancouver General Hospital
Vancouver, British Columbia, V6Z 2K8
About this study
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
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.
Read the 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.
- Conditions
- Cardiac Arrest Due to Underlying Cardiac Condition, Ventricular Fibrillation, Cardiopulmonary Arrest With Successful Resuscitation
- Being tested
- Initial CCL admission, Initial ICU admission
- Keywords
- Cardiac arrest, Ventricular fibrillation, coronary artery disease
- Medical subject headings
- Ventricular Fibrillation, Heart Arrest, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial CCL admissionProcedure or surgery
Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions
Initial ICU admissionDiagnostic test
Evaluate for additional testing and/or procedures
| Study group | Role | What they receive |
|---|---|---|
| Initial CCL admission | Experimental | Admission to the CCL to evaluate the coronary artery disease Receives: Procedure: Initial CCL admission |
| Initial ICU admission | Active comparator | Admission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team. Receives: Diagnostic Test: Initial ICU admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2017
- Study start12 Dec 2017
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Why it stopped: Low enrollment, funding withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cardiac Arrest Due to Underlying Cardiac ConditionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Demetris Yannopoulos, MD, Principal investigator, University of MinnesotaTom Aufderheide, MD, Principal investigator, MCW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03119571
- Sponsor's protocol ID
- CV-2017-25768
- Status last verified
- Jan 2021
- First submitted
- 29 Mar 2017
- Last updated
- 27 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03119571
- Acronym / sponsor ID
- CV-2017-25768
- Conditions
- Cardiac Arrest Due to Underlying Cardiac Condition, Ventricular Fibrillation, Cardiopulmonary Arrest With Successful Resuscitation
- Keywords
- Cardiac arrest, Ventricular fibrillation, coronary artery disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low enrollment, funding withdrawn
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 12 Dec 2017 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 18 Apr 2017 (actual)
- Results
- Posted 27 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Initial CCL admission | Experimental | Procedure: Initial CCL admissionAdmission to the CCL to evaluate the coronary artery disease |
| Initial ICU admission | Active comparator | Diagnostic Test: Initial ICU admissionAdmission to the ICU to be evaluated by clinical team and the clinical treatment will be decided by the admitting/attending team. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (13 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Initial CCL admissionAdmission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions | Procedure or surgery | Initial CCL admission |
| Initial ICU admissionEvaluate for additional testing and/or procedures | Diagnostic test | Initial ICU admission |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Demetris Yannopoulos, MD principal investigator
University of Minnesota
Tom Aufderheide, MD principal investigator
MCW
23 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Initial CCL admission and Initial ICU admission in people with Cardiac Arrest Due to Underlying Cardiac Condition and Ventricular Fibrillation, run by University of Minnesota at 23 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival to Hospital Discharge With mRS ≤ 3 (time frame: Up to 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2021.