Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
500 participants
INTERVENTIONAL
2018-01-30
2019-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Field Implementation of the autoRIC Device in STEMI
NCT03265067
Chronic Remote Ischemic Conditioning to Modify Post-MI Remodeling
NCT01817114
Long-term Remote Ischemic Preconditioning Improve the Prognosis of Myocardial Infarction Patients With Emergency Reperfusion Therapy
NCT03018873
Effects of Long-term Remote Ischemic Preconditioning on Clinical Outcome in Patients With Acute Myocardial Infarction
NCT07181356
Combined Application of Remote and Intra-Coronary Ischemic Conditioning in Acute Myocardial Infarction
NCT03155022
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
autoRIC
The autoRIC device will be used on subjects randomized to the treatment group.
autoRIC
Automated Remote Ischemic Conditioning
autoRIC Sham
The autoRIC Sham device will be used on subjects randomized to the control group.
autoRIC Sham
Automated Remote Ischemic Conditioning Sham
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
autoRIC
Automated Remote Ischemic Conditioning
autoRIC Sham
Automated Remote Ischemic Conditioning Sham
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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
3. Subject is willing and capable of providing written informed consent
4. 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
2. Subject has an elevated troponin level (cTnI or T) \> ULN at baseline, based on lab results obtained from the treating institution
3. Subject is scheduled to undergo PCI with the use of Propofol
4. 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
5. 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.)
6. Underwent a CABG in the last 4 weeks prior to baseline
7. Had a PCI within the last 7 days prior to baseline
8. Subject has a life expectancy \< 6 months
9. Subject has NYHA Class IV or decompensated heart failure
10. Subject has peripheral vascular disease requiring intervention during the index hospitalization or within 4 weeks post-procedure
11. 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
12. Subject has systolic blood pressure \> 200 mmHg
13. Subject is currently being treated with systemic oral or I.V. steroids
14. Subject has a known bleeding disorder or known abnormality of blood flow to the limb to be treated
15. Subject has peripheral nerve injury, abnormal nerve supply, peripheral neuropathy or pre-existing traumatic injury to the limb to be treated
16. Subject is scheduled for a PCI procedure to treat a known Chronic Total Occlusion (CTO) lesion
17. 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.)
18. 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.)
19. Any cardiac surgical procedure planned within 30 days post-enrollment
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
CellAegis US, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Roxana Mehran, MD
Role: PRINCIPAL_INVESTIGATOR
Cardiovascular Medicine Associates
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Alabama at Birmingham
Birmingham, Alabama, United States
Danbury Hospital
Danbury, Connecticut, United States
University of Florida Health Jacksonville
Jacksonville, Florida, United States
Iowa Heart Center
Des Moines, Iowa, United States
Henry Ford Hospital
Detroit, Michigan, United States
Henry Ford West Bloomfield Hospital
West Bloomfield, Michigan, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, United States
Southside Hospital
Bay Shore, New York, United States
North Shore University Hospital
Manhasset, New York, United States
Mount Sinai Hospital
New York, New York, United States
Lenox Hill Hospital
New York, New York, United States
Staten Island University Hospital
Staten Island, New York, United States
Novant Health Heart and Vascular Institute
Charlotte, North Carolina, United States
NC Heart and Vascular Research
Raleigh, North Carolina, United States
William Osler Health System
Brampton, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CS-000002 2013-SHIELD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.