Cardiac ArrestARRESTNCT03880565
Advanced Reperfusion Strategies for Refractory Cardiac Arrest
A study testing Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation and Standard Advanced Cardiac Life Support (ACLS) Resuscitation in people with Cardiac Arrest and Extracorporeal Membrane Oxygenation Complication, run by University of Minnesota at 1 site in United States.
Trial summary
This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication, Ventricular Fibrillation
- What is being tested?
- Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation and Standard Advanced Cardiac Life Support (ACLS) Resuscitation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Aug 2019to 9 Oct 2020
- 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
- Adults (presumed or known to be aged 18-75 years, inclusive),
- An initial documented OHCA rhythm of VF/VT,
- No ROSC following 3 defibrillation shocks,
- Body morphology able to accommodate a Lund University Cardiac Arrest System (LUCAS™) automated CPR device, and
- Estimated transfer time from the scene to the ED or CCL of < 30 minutes.
Who cannot join
- Age < 18 years old or > 75 years old;
- Non-shockable initial OHCA rhythm (pulseless electrical activity [PEA] or asystole);
- Valid do-not-attempt-resuscitation orders (DNAR);
- Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose;
- Known prisoners;
- Known pregnancy;
Show all 10Show fewer
- Nursing home residents;
- Unavailability of the cardiac catheterization laboratory.
- Severe concomitant illness that drastically shortens life expectancy or increases risk of the procedure;
- Absolute contraindications to emergent coronary angiography including known anaphylactic reaction to angiographic contrast media and/or active gastrointestinal or internal bleeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center, Fairview
Minneapolis, Minnesota, 55455
About this study
Official title: Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation
- Conditions
- Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication, Ventricular Fibrillation, Pulseless Ventricular Tachycardia, Out-Of-Hospital Cardiac Arrest
- Being tested
- Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation, Standard Advanced Cardiac Life Support (ACLS) Resuscitation
- Keywords
- advanced reperfusion, mechanical cardiopulmonary resuscitation
- Medical subject headings
- Heart Arrest, Ventricular Fibrillation, Out-of-Hospital Cardiac Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated ResuscitationDevice
Early use of ECMO
Standard Advanced Cardiac Life Support (ACLS) ResuscitationDevice
Standard life support resuscitation
| Study group | Role | What they receive |
|---|---|---|
| ECMO Facilitated Resuscitation | Experimental | Regardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, patients will enter the Cardiac Catheterization Laboratory (CCL) for expeditious VAECMO initiation, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate. Receives: Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation |
| Standard ACLS Resuscitation | Other | Patients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI, and potential VA ECMO or other circulatory support device initiation, as clinically indicated. Receives: Device: Standard Advanced Cardiac Life Support (ACLS) Resuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
Number of participants who survived to hospital discharge
Measured: Approximately 25 days
Secondary outcomes (3)
Modified Rankin Scale (mRS) Score
mRS scale ranges from 0 (no residual symptoms) to 6 (dead). Scores of 3 (the patient has moderate disability), 2 (the patient has slight disability), 1 (the patient has no significant disability), and 0 indicate favorable outcome. Higher scores on the scale indicate more severe disability. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following.
Measured: At hospital discharge (average of 25 days), 3 months, 6 months
Cerebral Performance Categories (CPC) Scale
CPC scale ranges from 1 (good cerebral performance) to 5 (brain death). CPC scores of 2 (moderate cerebral disability) and 1 indicate functional status. Higher scores on the scale indicate worse cerebral performance. Outcome is reported as the mean score. Outcome is collected and reported at hospital discharge (average of 25 days) and at three and six months following.
Measured: At hospital discharge (average of 25 days), 3 months, 6 months
Treatment Cost
Outcome is reported as the mean treatment cost in dollars.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2019
- Study start9 Aug 2019
- Primary completion9 Oct 2020
- Study completion9 Oct 2020
Why it stopped: For early efficacy
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 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, Study chair, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03880565
- Sponsor's protocol ID
- CV-2018-27226
- Acronym
- ARREST
- Status last verified
- Feb 2022
- First submitted
- 11 Mar 2019
- Last updated
- 10 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13.
PubMed 33197396
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced REperfusion STrategies for Refractory Cardiac Arrest (The ARREST Trial)
- ClinicalTrials.gov ID
- NCT03880565
- Acronym / sponsor ID
- ARREST / CV-2018-27226
- Conditions
- Cardiac Arrest, Extracorporeal Membrane Oxygenation Complication, Ventricular Fibrillation, Pulseless Ventricular Tachycardia, Out-Of-Hospital Cardiac Arrest
- Keywords
- advanced reperfusion, mechanical cardiopulmonary resuscitation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: For early efficacy
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 9 Aug 2019 (actual)
- Primary completion
- 9 Oct 2020 (actual)
- Study completion
- 9 Oct 2020 (actual)
- First posted
- 19 Mar 2019 (actual)
- Results
- Posted 22 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II, single center (Under the Center for Resuscitation Medicine at the University of Minnesota Medical School), partially blinded, prospective, intention to treat, safety and efficacy clinical trial, randomizing adult patients (18-75 years old) with refractory ventricular fibrillation/pulseless ventricular tachycardia (VF/VT) out-of hospital cardiac arrest (OHCA) who are transferred by emergency medical services (EMS) with ongoing mechanical cardiopulmonary resuscitation (CPR) or who are resuscitated to receive one of the 2 local standards of care practiced in our community: 1) Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation or 2) Standard Advanced Cardiac Life Support (ACLS) Resuscitation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECMO Facilitated Resuscitation | Experimental | Device: Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated ResuscitationRegardless of whether return of spontaneous circulation (ROSC) has been achieved and with on-going mechanical CPR, patients will enter the Cardiac Catheterization Laboratory (CCL) for expeditious VAECMO initiation, if required, followed by coronary angiography and percutaneous coronary intervention (PCI) when appropriate. |
| Standard ACLS Resuscitation | Other | Device: Standard Advanced Cardiac Life Support (ACLS) ResuscitationPatients with refractory VF/VT OHCA will be treated with ACLS resuscitation for at least 15 minutes after arrival in the emergency department (ED), or up to 60 minutes from 911 call, after which the physician (MD) can continue resuscitation efforts until ROSC is achieved or futility has been reached based on their clinical judgment. If the patient has not achieved ROSC during the times mentioned above, the ED MD can declare death when he or she believes that ACLS is futile. If ROSC is present upon arrival or has been achieved anytime during resuscitation in the ED, the patient will be taken to the cardiac catheterization laboratory (CCL) for coronary angiography and PCI, and potential VA ECMO or other circulatory support device initiation, as clinically indicated. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults (presumed or known to be aged 18-75 years, inclusive),
- An initial documented OHCA rhythm of VF/VT,
- No ROSC following 3 defibrillation shocks,
- Body morphology able to accommodate a Lund University Cardiac Arrest System (LUCAS™) automated CPR device, and
- Estimated transfer time from the scene to the ED or CCL of < 30 minutes.
Key exclusion criteria (10 listed)
- Age < 18 years old or > 75 years old;
- Non-shockable initial OHCA rhythm (pulseless electrical activity [PEA] or asystole);
- Valid do-not-attempt-resuscitation orders (DNAR);
- Blunt, penetrating, or burn-related injury, drowning, electrocution or known overdose;
- Known prisoners;
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 |
|---|---|---|
| Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated ResuscitationEarly use of ECMO | Device | ECMO Facilitated Resuscitation |
| Standard Advanced Cardiac Life Support (ACLS) ResuscitationStandard life support resuscitation | Device | Standard ACLS Resuscitation |
Primary outcome
Survival
Time frame: Approximately 25 days
Number of participants who survived to hospital discharge
3 secondary outcomes
Modified Rankin Scale (mRS) Score
Time frame: At hospital discharge (average of 25 days), 3 months, 6 months
Cerebral Performance Categories (CPC) Scale
Time frame: At hospital discharge (average of 25 days), 3 months, 6 months
Treatment Cost
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33197396Yannopoulos D, Bartos J, Raveendran G, Walser E, Connett J, Murray TA, Collins G, Zhang L, Kalra R, Kosmopoulos M, John R, Shaffer A, Frascone RJ, Wesley K, Conterato M, Biros M, Tolar J, Aufderheide TP. Advanced reperfusion strategies for patients with out-of-hospital cardiac arrest and refractory ventricular fibrillation (ARREST): a phase 2, single centre, open-label, randomised controlled trial. Lancet. 2020 Dec 5;396(10265):1807-1816. doi: 10.1016/S0140-6736(20)32338-2. Epub 2020 Nov 13.
- Individual participant dataSharing planned: No
Related trials for Cardiac Arrest
RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock
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 study chair
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation and Standard Advanced Cardiac Life Support (ACLS) Resuscitation in people with Cardiac Arrest and Extracorporeal Membrane Oxygenation Complication, run by University of Minnesota at 1 site in United States.
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 5 inclusion and 10 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 22 Nov 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 (time frame: Approximately 25 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03880565, which also lists 1 linked publication.
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 10 Mar 2022.