- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03318575
Remote Ischemic Conditioning Using the autoRIC (SHIELD)
Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Vera Belaoussoff
- Phone Number: 105 647-722-9601
- Email: vbelaoussoff@cellaegisdevices.com
Study Contact Backup
- Name: Brad Solberg
- Phone Number: 408-400-0856
- Email: brad@experiengroup.com
Study Locations
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Ontario
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Brampton, Ontario, Canada, L6R 3J7
- Recruiting
- William Osler Health System
-
Contact:
- James Kemp, BS
- Phone Number: 58666 905-494-2120
- Email: James.kemp@williamoslerhs.ca
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Principal Investigator:
- Shy Amlani, MD
-
Toronto, Ontario, Canada, M5B 1W8
- Recruiting
- St. Michael's Hospital
-
Contact:
- Ivana Kandic, MSc.
- Phone Number: 6120 416-864-6060
- Email: kandici@smh.ca
-
Principal Investigator:
- Akshay Bagai, MD
-
-
-
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Alabama
-
Birmingham, Alabama, United States, 35294
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Patrick Frazier, RN
- Phone Number: 205-934-5774
- Email: CCTU@uabmc.edu
-
Principal Investigator:
- Massoud Leesar, MD
-
-
Connecticut
-
Danbury, Connecticut, United States, 06810
- Recruiting
- Danbury Hospital
-
Contact:
- Monica Tawadros, MPH
- Phone Number: 203-739-7134
- Email: Monica.Tawadros@wchn.org
-
Principal Investigator:
- Hal Wasserman, MD
-
-
Florida
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Jacksonville, Florida, United States, 32209
- Recruiting
- University of Florida Health Jacksonville
-
Contact:
- Emily Green, BSN, RN
- Phone Number: 904-244-2794
- Email: emily.green@jax.ufl.edu
-
Principal Investigator:
- Andres Pineda Maldonado, MD
-
-
Iowa
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Des Moines, Iowa, United States, 50314
- Recruiting
- Iowa Heart Center
-
Contact:
- Kassandra Seitz, BSN, RN
- Phone Number: 515-235-5114
- Email: kseitz@iowaheart.com
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-
Michigan
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Detroit, Michigan, United States, 48202
- Recruiting
- Henry Ford Hospital
-
Contact:
- Margaret Fox, RN, BSN
- Phone Number: 313-916-1879
- Email: mfox2@hfhs.org
-
Principal Investigator:
- Gerald Koenig, MD, PhD
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West Bloomfield, Michigan, United States, 48322
- Recruiting
- Henry Ford West Bloomfield Hospital
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Principal Investigator:
- Gerald Koenig, MD, PhD
-
Contact:
- Mishel Tabaku
- Phone Number: 248-325-0737
- Email: Mtabaku1@hfhs.org
-
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Missouri
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Kansas City, Missouri, United States, 64111
- Recruiting
- Saint Luke's Hospital of Kansas City
-
Contact:
- Lisa Lacy, RCIS
- Phone Number: 816-932-7528
- Email: lnewhouse@saint-lukes.org
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Principal Investigator:
- John Saxon, MD
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New York
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Bay Shore, New York, United States, 11706
- Recruiting
- Southside Hospital
-
Contact:
- Barbara Shannon, RN, BSN
- Phone Number: 631-968-3016
- Email: bshannon@northwell.edu
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Manhasset, New York, United States, 11030
- Recruiting
- North Shore University Hospital
-
Contact:
- Ruby Garzon, RN, MSN
- Phone Number: 516-562-4168
- Email: rgrazon@northwell.edu
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New York, New York, United States, 10029
- Recruiting
- Mount Sinai Hospital
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Contact:
- Nicole Saint Vrestil, BA
- Phone Number: 212-241-9687
- Email: nicole.saintvrestil@mountsinai.org
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Principal Investigator:
- Joseph Sweeney, MD
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New York, New York, United States, 10075
- Recruiting
- Lenox Hill Hospital
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Contact:
- Priscilla Chu, BA
- Phone Number: 212-434-3362
- Email: Pchu3@northwell.edu
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Staten Island, New York, United States, 10305
- Recruiting
- Staten Island University Hospital
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Contact:
- Richie Dima, MD
- Phone Number: 718-226-1489
- Email: rdima@northwell.edu
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North Carolina
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Charlotte, North Carolina, United States, 28204
- Recruiting
- Novant Health Heart and Vascular Institute
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Contact:
- Pailing Richards, RN, BSN
- Phone Number: 704-264-1400
- Email: pcrichards@novanthealth.org
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Principal Investigator:
- Amjad Almahameed, MD
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Raleigh, North Carolina, United States, 27607
- Recruiting
- NC Heart and Vascular Research
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Contact:
- James R Pierre-Louis, MD, CRS
- Phone Number: 919-784-7695
- Email: james.pierre-louis@unchealth.unc.edu
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Principal Investigator:
- Mohit Pasi, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: autoRIC
The autoRIC device will be used on subjects randomized to the treatment group.
|
Automated Remote Ischemic Conditioning
|
SHAM_COMPARATOR: autoRIC Sham
The autoRIC Sham device will be used on subjects randomized to the control group.
|
Automated Remote Ischemic Conditioning Sham
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
(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.
|
12-24 hours
|
(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.
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Type 4a Myocardial Infarction (MI)
Time Frame: 12-24 hours
|
The proportion of subjects with a Type 4a MI within 12-24 hours post- PCI.
|
12-24 hours
|
Contrast-Induced Acute Kidney Injury (CI-AKI)
Time Frame: 12-24 hours
|
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.
|
12-24 hours
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Roxana Mehran, MD, Cardiovascular Medicine Associates
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CS-000002 2013-SHIELD
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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