Ischemia-Reperfusion InjurySHIELDNCT03318575
Remote Ischemic Conditioning Using the autoRIC
A study testing autoRIC in people with Ischemia-Reperfusion Injury, run by CellAegis US, Inc. at 16 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate the hypothesis that patients receiving remote ischemic conditioning using the autoRIC device show statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in the autoRIC Sham device arm (within 12-24 hours… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemia-Reperfusion Injury
- What is being tested?
- autoRIC
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 500 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 30 Jan 2018to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Subject is ≥ 18 years of age
- Subject is scheduled for elective PCI, or unscheduled but non-emergent PCI, or diagnostic catheterization with PCI if indicated. For non-elective cases, there must be at least two troponin levels within the upper limit of normal (ULN), at least 6 hours apart prior to the index procedure
- Subject is willing and capable of providing written informed consent
- If the subject is a woman of childbearing potential, she must have had a negative pregnancy test within 24 hours of the study procedure
Who cannot join
- Subject requires emergency PCI (i.e., PCI for evolving or ongoing STEMI/NSTEMI)
- Subject has an elevated troponin level (cTnI or T) > ULN at baseline, based on lab results obtained from the treating institution
- Subject is scheduled to undergo PCI with the use of Propofol
- Subject has a recent history of drug treatment with potassium channel activators (e.g., Nicorandil) or potassium channel blockers (e.g., sulfonylureas) during the last 7 days prior to baseline
- Subject had STEMI during the last 4 weeks prior to baseline. (Note: NSTEMI in the last 4 weeks prior to baseline is allowed if the baseline troponin is ≤ ULN.)
- Underwent a CABG in the last 4 weeks prior to baseline
Show all 19Show fewer
- Had a PCI within the last 7 days prior to baseline
- Subject has a life expectancy < 6 months
- Subject has NYHA Class IV or decompensated heart failure
- Subject has peripheral vascular disease requiring intervention during the index hospitalization or within 4 weeks post-procedure
- Subject has either serum creatinine >2 times the age-appropriate upper limit of normal, a glomerular filtration rate (GFR) of < 30 mL/min/1.73m2 or requires dialysis
- Subject has systolic blood pressure > 200 mmHg
- Subject is currently being treated with systemic oral or I.V. steroids
- Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated
- Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated
- Subject is scheduled for a PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
- Subject is currently participating in or is planning to participate in another investigational drug or device trial, prior to the 30-day follow-up visit. (Note: Observational studies or post-approval studies/ registries, are allowed.)
- Planned (staged) post-index procedure intervention within 30 days (i.e., PCI of non-target lesions in any vessel or CABG). (Note: Planned revascularization (PCI or bypass) of a non-target lesion >30 days following the index procedure is allowed.)
- Any cardiac surgical procedure planned within 30 days post-enrollment
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
United States14 sites, 14 recruiting
- Recruiting
Southside Hospital
Bay Shore, New York, 11706
Barbara Shannon, RN, BSN, 631-968-3016, bshannon@northwell.edu
Cindy Grines, MD
- Recruiting
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Patrick Frazier, RN, 205-934-5774, CCTU@uabmc.edu
Massoud Leesar, MD
- Recruiting
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, 28204
Pailing Richards, RN, BSN, 704-264-1400, pcrichards@novanthealth.org
Amjad Almahameed, MD
- Recruiting
Danbury Hospital
Danbury, Connecticut, 06810
Monica Tawadros, MPH, 203-739-7134, Monica.Tawadros@wchn.org
Hal Wasserman, MD
- Recruiting
Iowa Heart Center
Des Moines, Iowa, 50314
Kassandra Seitz, BSN, RN, 515-235-5114, kseitz@iowaheart.com
Magdi Ghali, MD
- Recruiting
Henry Ford Hospital
Detroit, Michigan, 48202
Margaret Fox, RN, BSN, 313-916-1879, mfox2@hfhs.org
Gerald Koenig, MD, PhD
- Recruiting
University of Florida Health Jacksonville
Jacksonville, Florida, 32209
Emily Green, BSN, RN, 904-244-2794, emily.green@jax.ufl.edu
Andres Pineda Maldonado, MD
- Recruiting
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111
Lisa Lacy, RCIS, 816-932-7528, lnewhouse@saint-lukes.org
John Saxon, MD
- Recruiting
North Shore University Hospital
Manhasset, New York, 11030
Ruby Garzon, RN, MSN, 516-562-4168, rgrazon@northwell.edu
Cindy Grines, MD
- Recruiting
Mount Sinai Hospital
New York, New York, 10029
Nicole Saint Vrestil, BA, 212-241-9687, nicole.saintvrestil@mountsinai.org
Joseph Sweeney, MD
- Recruiting
Lenox Hill Hospital
New York, New York, 10075
Priscilla Chu, BA, 212-434-3362, Pchu3@northwell.edu
Cindy Grines, MD
- Recruiting
NC Heart and Vascular Research
Raleigh, North Carolina, 27607
James R Pierre-Louis, MD, CRS, 919-784-7695, james.pierre-louis@unchealth.unc.edu
Mohit Pasi, MD
- Recruiting
Staten Island University Hospital
Staten Island, New York, 10305
Richie Dima, MD, 718-226-1489, rdima@northwell.edu
Cindy Grines, MD
- Recruiting
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, 48322
Mishel Tabaku, 248-325-0737, Mtabaku1@hfhs.org
Gerald Koenig, MD, PhD
Canada2 sites, 2 recruiting
- Recruiting
William Osler Health System
Brampton, Ontario, L6R 3J7
James Kemp, BS, 905-494-2120 ext. 58666, James.kemp@williamoslerhs.ca
Shy Amlani, MD
- Recruiting
St. Michael's Hospital
Toronto, Ontario, M5B 1W8
Ivana Kandic, MSc., 416-864-6060 ext. 6120, kandici@smh.ca
Akshay Bagai, MD
About this study
Official title: Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study
The purpose of the study is to evaluate the hypothesis that patients receiving remote ischemic conditioning using the autoRIC device show statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in the autoRIC Sham device arm (within 12-24 hours post non-emergent PCI with stent implantation).
Read the detailed description
This is a multi-center, randomized, controlled single-blind clinical trial to evaluate the safety and effectiveness of the autoRIC device to attenuate myocardial injury as measured by cardiac Troponin I (cTnI) levels in patients undergoing PCI with stent implantation.
Eligible patients that are scheduled for an elective PCI, or unscheduled/non-emergent PCI, or patients scheduled for a diagnostic catheterization procedure with orders of "treat as indicated" will be enrolled in the study. Patients will undergo remote ischemic conditioning with the autoRIC device or the control procedure with the autoRIC Sham device completed ≤ 1 hour prior to balloon or stent inflation. Subjects will have measurements of cTnI levels at baseline and 4-8 and 12-24 hours post completion of the PCI procedure. Adverse events will be recorded through study exit for all patients. Patients will be exited from the study after completion of their 30-day post-procedure telephone follow-up.
- Conditions
- Ischemia-Reperfusion Injury
- Being tested
- autoRIC, autoRIC Sham
- Keywords
- remote ischemic conditioning (RIC), percutaneous coronary intervention, PCI, cardiac troponin I, cardiac catheterization, myocardial injury, myocardial necrosis, autoRIC, Ischemia-Reperfusion Injury (IRI), Automated Remote Ischemic Conditioning
- Medical subject headings
- Reperfusion Injury, Cardiomyopathy, Dilated, 1FF, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autoRICDevice
Automated Remote Ischemic Conditioning
autoRIC ShamDevice
Automated Remote Ischemic Conditioning Sham
| Study group | Role | What they receive |
|---|---|---|
| autoRIC | Experimental | The autoRIC device will be used on subjects randomized to the treatment group. Receives: Device: autoRIC |
| autoRIC Sham | Sham comparator | The autoRIC Sham device will be used on subjects randomized to the control group. Receives: Device: autoRIC Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
(Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI)
The proportion of subjects with cTnI levels above the 99th percentile Upper Reference Limit (URL) (0.04 ng/mL) 12-24 hours post-PCI.
Measured: 12-24 hours
(Primary Safety) Major Adverse Cardiac Events (MACE)
The proportion of subjects with major adverse cardiac events (MACE) within 30 days. MACE is defined as: death, stroke, myocardial infarction or the need for target vessel revascularization.
Measured: 30 days
Secondary outcomes (2)
Type 4a Myocardial Infarction (MI)
The proportion of subjects with a Type 4a MI within 12-24 hours post- PCI.
Measured: 12-24 hours
Contrast-Induced Acute Kidney Injury (CI-AKI)
The proportion of subjects with CI-AKI defined as > 25% or 0.5 mg/dl increase in serum creatinine above baseline within 12-24 hours post-PCI.
Measured: 12-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2017
- Study start30 Jan 2018
- Primary completionApr 2019 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemia-Reperfusion InjuryStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CellAegis US, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roxana Mehran, MD, Principal investigator, Cardiovascular Medicine Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03318575
- Sponsor's protocol ID
- CS-000002 2013-SHIELD
- Acronym
- SHIELD
- Status last verified
- Aug 2018
- First submitted
- 19 Oct 2017
- Last updated
- 31 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study
- ClinicalTrials.gov ID
- NCT03318575
- Acronym / sponsor ID
- SHIELD / CS-000002 2013-SHIELD
- Conditions
- Ischemia-Reperfusion Injury
- Keywords
- remote ischemic conditioning (RIC), percutaneous coronary intervention, PCI, cardiac troponin I, cardiac catheterization, myocardial injury, myocardial necrosis, autoRIC
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- CellAegis US, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- Apr 2019 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 24 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to evaluate the hypothesis that patients receiving remote ischemic conditioning using the autoRIC device show statistically significant reduction in the prevalence of ischemia-reperfusion injury to the myocardium as compared to patients in the autoRIC Sham device arm (within 12-24 hours post non-emergent PCI with stent implantation).
Detailed description
This is a multi-center, randomized, controlled single-blind clinical trial to evaluate the safety and effectiveness of the autoRIC device to attenuate myocardial injury as measured by cardiac Troponin I (cTnI) levels in patients undergoing PCI with stent implantation.
Eligible patients that are scheduled for an elective PCI, or unscheduled/non-emergent PCI, or patients scheduled for a diagnostic catheterization procedure with orders of "treat as indicated" will be enrolled in the study. Patients will undergo remote ischemic conditioning with the autoRIC device or the control procedure with the autoRIC Sham device completed ≤ 1 hour prior to balloon or stent inflation. Subjects will have measurements of cTnI levels at baseline and 4-8 and 12-24 hours post completion of the PCI procedure. Adverse events will be recorded through study exit for all patients. Patients will be exited from the study after completion of their 30-day post-procedure telephone follow-up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| autoRIC | Experimental | Device: autoRICThe autoRIC device will be used on subjects randomized to the treatment group. |
| autoRIC Sham | Sham comparator | Device: autoRIC ShamThe autoRIC Sham device will be used on subjects randomized to the control group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is ≥ 18 years of age
- Subject is scheduled for elective PCI, or unscheduled but non-emergent PCI, or diagnostic catheterization with PCI if indicated. For non-elective cases, there must be at least two troponin levels within the upper limit of normal (ULN), at least 6 hours apart prior to the index procedure
- Subject is willing and capable of providing written informed consent
- If the subject is a woman of childbearing potential, she must have had a negative pregnancy test within 24 hours of the study procedure
Key exclusion criteria (19 listed)
- Subject requires emergency PCI (i.e., PCI for evolving or ongoing STEMI/NSTEMI)
- Subject has an elevated troponin level (cTnI or T) > ULN at baseline, based on lab results obtained from the treating institution
- Subject is scheduled to undergo PCI with the use of Propofol
- Subject has a recent history of drug treatment with potassium channel activators (e.g., Nicorandil) or potassium channel blockers (e.g., sulfonylureas) during the last 7 days prior to baseline
- Subject had STEMI during the last 4 weeks prior to baseline. (Note: NSTEMI in the last 4 weeks prior to baseline is allowed if the baseline troponin is ≤ ULN.)
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 |
|---|---|---|
| autoRICAutomated Remote Ischemic Conditioning | Device | autoRIC |
| autoRIC ShamAutomated Remote Ischemic Conditioning Sham | Device | autoRIC Sham |
Primary outcome
(Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI)
Time frame: 12-24 hours
The proportion of subjects with cTnI levels above the 99th percentile Upper Reference Limit (URL) (0.04 ng/mL) 12-24 hours post-PCI.
(Primary Safety) Major Adverse Cardiac Events (MACE)
Time frame: 30 days
The proportion of subjects with major adverse cardiac events (MACE) within 30 days. MACE is defined as: death, stroke, myocardial infarction or the need for target vessel revascularization.
2 secondary outcomes
Type 4a Myocardial Infarction (MI)
Time frame: 12-24 hours
Contrast-Induced Acute Kidney Injury (CI-AKI)
Time frame: 12-24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Individual participant dataSharing planned: No
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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.
Roxana Mehran, MD principal investigator
Cardiovascular Medicine Associates
16 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing autoRIC in people with Ischemia-Reperfusion Injury, run by CellAegis US, Inc. at 16 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 19 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: status not confirmed, as of the sponsor's last update on 31 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vera Belaoussoff (647-722-9601 ext. 105, vbelaoussoff@cellaegisdevices.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(Primary Effectiveness) Attenuation of myocardial injury assessed by Cardiac Troponin I levels (cTnI) (time frame: 12-24 hours). The study lists 2 primary outcomes in all. 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 31 Aug 2018.