Cardiac ArrestNCT04265807
Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot
A study testing Active Remote Ischemic Conditioning in people with Cardiac Arrest, run by University of Washington at 1 site in United States.
Trial summary
Following resuscitation from out-of-hospital cardiac arrest (OHCA), reperfusion injury can cause cell damage in the heart and brain. Remote ischemic conditioning (RIC) consists of intermittent application of a device such as a blood pressure cuff to a limb to induce non-lethal ischemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- Active Remote Ischemic Conditioning
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2020to 3 Feb 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Included will be those with:
- Age 18 years or more;
- Defibrillation by laypersons or defibrillation and/or chest compressions by EMS providers dispatched to the scene;
- Non-traumatic etiology of arrest, defined as without concomitant blunt, penetrating, or burn-related injury, or uncontrolled bleeding or exsanguination;
- Spontaneous circulation upon emergency department arrival;
- No response to verbal commands; and
- Ongoing or planned induced hypothermia.
Excluded will be those with:
- STEMI indicated on first 12-lead ECG obtained after restoration of circulation, defined as ST-elevation of ≥2 mm in two or more contiguous ECG leads;
- Written do not attempt resuscitation (DNAR) reported to providers before randomization;
- Drowning or hypothermia as cause of arrest;
- Known prisoner or pregnant; or
- Dialysis fistula in either upper extremity; or
- Pre-existing amputation of upper extremity.
Trial locations and contacts
1 site in 1 country.
About this study
Following resuscitation from out-of-hospital cardiac arrest (OHCA), reperfusion injury can cause cell damage in the heart and brain. Remote ischemic conditioning (RIC) consists of intermittent application of a device such as a blood pressure cuff to a limb to induce non-lethal ischemia. Studies in animals with cardiac arrest as well as in humans with acute myocardial infarction suggest that RIC before or after restoration of blood flow may reduce injury to the heart and improve outcomes but this has not been proven in humans who have had OHCA. The RICE pilot study is a single-center study to assess the feasibility of application of RIC in the emergency department setting for patients transported to the hospital after resuscitation from OHCA.
- Conditions
- Cardiac Arrest
- Being tested
- Active Remote Ischemic Conditioning, Sham Remote Ischemic Conditioning
- Keywords
- reperfusion injury, remote ischemic conditioning
- Medical subject headings
- Heart Arrest, Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Remote Ischemic ConditioningDevice
A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on a upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods.
Sham Remote Ischemic ConditioningDevice
The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Active comparator | A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. Receives: Device: Active Remote Ischemic Conditioning |
| Control Group | Sham comparator | The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. Receives: Device: Sham Remote Ischemic Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attrition
Attrition assessed as the proportion of randomized subjects who do not remain on allocated therapy for the intended study duration among subjects randomly allocated. On therapy for the intended study duration consists of completing three cycles of inflation-deflation.
Measured: Completion of their allocated study intervention, an average of 30 minutes from enrollment
Secondary outcomes (13)
Treatment Success
Treatment Success assessed as the proportion of intervention group patients who remain alive and on their allocated therapy for the intended study duration.
Measured: 30 minutes from initiation of study intervention
Cardiac Function
Cardiac Function assessed as left ventricular ejection fraction (LVEF) using echocardiograms ordered for clinical indications.
Measured: Within 48 hours of index arrest
Proportion With Cardiogenic Shock, %
Cardiogenic Shock assessed as systolic BP < 80 mmHg during any 6 h period within 48 h of the index arrest not due to a correctable cause, and treated with pressors or inotropes or placement of a mechanical cardiac assist device (e.g. intra-aortic balloon pump). Cardiogenic shock correlates with survival after resuscitation from cardiac arrest.
Measured: Within 48 hours of index arrest
STEMI
STEMI assessed as the presence of electrocardiographic (ECG) and biomarker criteria for acute myocardial infarction within 48 h of the index arrest. Note that ST-elevation on the first 12-lead ECG after resuscitation is a poor predictor of acute infarction in this population. These patients often develop infarctions during the subsequent 48 h.
Measured: Within 48 hours of index arrest
Myocardial Injury
Myocardial Injury assessed as peak serum troponin in ng/mL at any time point within 24 h of index arrest.
Measured: Within 24 hours of index arrest
Renal Dysfunction
Renal Dysfunction assessed using Risk, Injury, Failure, Loss, End Stage criteria.
Measured: Within 24 hours of index arrest
Hospital Free Survival
Hospital Free Survival (HFS) assessed as number of days alive and permanently out of hospital up to 30 days post arrest
Measured: Within 30 days of index arrest
Withdrawal of Care
assessed as the reduction of support (i.e. reducing pressors, lab draws or medications) or withdrawal of support (i.e. extubation, stopping drips/meds, changing to comfort care only) during hospitalization.
Measured: Discharge or 30 days after index arrest
Favourable Neurologic Status at Discharge
Favourable Neurologic Status at Discharge assessed using modified Rankin Score (MRS) < 3 at hospital discharge or 30 days after index arrest. Modified Rankin Scale is scored from zero to six. Higher values represent a worse outcome. Favorable neurologic status is defined as a modified Rankin score 0, 1 or 2.
Measured: Discharge or 30 days after index arrest
Survival to Discharge
Survival to Discharge assessed as alive when discharged from hospital to home, nursing facility or rehabilitation. Patients transferred to another acute care facility (e.g. to undergo implantable defibrillator placement) will be considered still hospitalized.
Measured: Discharge or 30 days after index arrest
Clinical Instability at Discharge
Clinical Instability at Discharge assessed using the Kosecoff Index measured at discharge based on the presence of nine symptoms and signs associated with increased risk of rehospitalization. Instability will be the presence of any of these.
Clinical instability at discharge was defined by the Kosecoff Index. https://pubmed.ncbi.nlm.nih.gov/2214063/
This was scored as 1 point for the presence and 0 for the absence of each of the following during the 24 h prior to discharge:
Fever, temperature >38.3°C Urinary incontinence Chest pain Shortness of breath Confusion Heart rate >=130 beats/min Respiratory rate >=30/min Diastolic blood pressure >= 105 mmHg Systolic blood pressure < 90 mmHg Heart rate < 50 bpm Premature ventricular contractions on telemetry
Measured: Discharge or 30 days after index arrest
Survival to 30 Days After Arrest
Survival to 30 Days After Cardiac Arrest assessed as alive 30 days after the index cardiac arrest as confirmed by a brief telephone interview.
Measured: 30 days after index arrest
Accrual
Accrual is the proportion of eligible subjects who have the study device applied
Measured: Before leaving the emergency department
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2020
- Study start1 Jul 2020
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
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 ArrestStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Charles F. Kettering Foundation
- Responsible party
- Principal investigator, Graham Nichol, University of Washington
- Investigators
- Graham Nichol, MD, MPH, Principal investigator, University of WashingtonEmilby S Bartlett, MD MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265807
- Sponsor's protocol ID
- STUDY00005176
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2020
- Last updated
- 4 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Available upon request, subject to mutual agreement
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Ischemic Conditioning to Enhance Resuscitation (RICE) Pilot
- ClinicalTrials.gov ID
- NCT04265807
- Acronym / sponsor ID
- STUDY00005176
- Conditions
- Cardiac Arrest
- Keywords
- reperfusion injury, remote ischemic conditioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Charles F. Kettering Foundation
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 12 Feb 2020 (actual)
- Results
- Posted 4 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following resuscitation from out-of-hospital cardiac arrest (OHCA), reperfusion injury can cause cell damage in the heart and brain. Remote ischemic conditioning (RIC) consists of intermittent application of a device such as a blood pressure cuff to a limb to induce non-lethal ischemia. Studies in animals with cardiac arrest as well as in humans with acute myocardial infarction suggest that RIC before or after restoration of blood flow may reduce injury to the heart and improve outcomes but this has not been proven in humans who have had OHCA. The RICE pilot study is a single-center study to assess the feasibility of application of RIC in the emergency department setting for patients transported to the hospital after resuscitation from OHCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Active comparator | Device: Active Remote Ischemic ConditioningA standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on an upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. |
| Control Group | Sham comparator | Device: Sham Remote Ischemic ConditioningThe control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Active Remote Ischemic ConditioningA standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on a upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods. | Device | Intervention Group |
| Sham Remote Ischemic ConditioningThe control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group. | Device | Control Group |
Primary outcome
Attrition
Time frame: Completion of their allocated study intervention, an average of 30 minutes from enrollment
Attrition assessed as the proportion of randomized subjects who do not remain on allocated therapy for the intended study duration among subjects randomly allocated. On therapy for the intended study duration consists of completing three cycles of inflation-deflation.
13 secondary outcomes
Treatment Success
Time frame: 30 minutes from initiation of study intervention
Cardiac Function
Time frame: Within 48 hours of index arrest
Proportion With Cardiogenic Shock, %
Time frame: Within 48 hours of index arrest
STEMI
Time frame: Within 48 hours of index arrest
Myocardial Injury
Time frame: Within 24 hours of index arrest
Renal Dysfunction
Time frame: Within 24 hours of index arrest
Hospital Free Survival
Time frame: Within 30 days of index arrest
Withdrawal of Care
Time frame: Discharge or 30 days after index arrest
Favourable Neurologic Status at Discharge
Time frame: Discharge or 30 days after index arrest
Survival to Discharge
Time frame: Discharge or 30 days after index arrest
Clinical Instability at Discharge
Time frame: Discharge or 30 days after index arrest
Survival to 30 Days After Arrest
Time frame: 30 days after index arrest
Accrual
Time frame: Before leaving the emergency department
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Available upon request, subject to mutual agreement
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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.
Graham Nichol, MD, MPH principal investigator
University of Washington
Emilby S Bartlett, MD MS principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Remote Ischemic Conditioning in people with Cardiac Arrest, run by University of Washington 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?
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: finished, as of the sponsor's last update on 4 Feb 2025. 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. Some participants in this study may receive a placebo. 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 4 Feb 2025). 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?
Attrition (time frame: Completion of their allocated study intervention, an average of 30 minutes from enrollment). 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 4 Feb 2025.