Remote Ischemic Conditioning Using the autoRIC

Ischemia-Reperfusion Injury Clinical Trial

— SHIELD  

Official title:

Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03318575
• Other study ID #: CS-000002 2013-SHIELD
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2018
• Est. completion date: April 2019

Study information

• Verified date: August 2018
• Source: CellAegis US, Inc.
• Contact: Vera Belaoussoff
• Phone: 647-722-9601
• Email: vbelaoussoff[@]cellaegisdevices.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 post non-emergent PCI with stent implantation).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Subject is = 18 years of age

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:

1. Subject requires emergency PCI (i.e., PCI for evolving or ongoing STEMI/NSTEMI)

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

Related Conditions & MeSH terms

• Ischemia
• Ischemia-Reperfusion Injury
• Reperfusion Injury

Intervention

Device:
• autoRIC
Automated Remote Ischemic Conditioning
• autoRIC Sham
Automated Remote Ischemic Conditioning Sham

Locations

Country	Name	City	State
Canada	William Osler Health System	Brampton	Ontario
Canada	St. Michael's Hospital	Toronto	Ontario
United States	Southside Hospital	Bay Shore	New York
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Novant Health Heart and Vascular Institute	Charlotte	North Carolina
United States	Danbury Hospital	Danbury	Connecticut
United States	Iowa Heart Center	Des Moines	Iowa
United States	Henry Ford Hospital	Detroit	Michigan
United States	University of Florida Health Jacksonville	Jacksonville	Florida
United States	Saint Luke's Hospital of Kansas City	Kansas City	Missouri
United States	North Shore University Hospital	Manhasset	New York
United States	Lenox Hill Hospital	New York	New York
United States	Mount Sinai Hospital	New York	New York
United States	NC Heart and Vascular Research	Raleigh	North Carolina
United States	Staten Island University Hospital	Staten Island	New York
United States	Henry Ford West Bloomfield Hospital	West Bloomfield	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
CellAegis US, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	(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.	12-24 hours
Primary	(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.	30 days
Secondary	Type 4a Myocardial Infarction (MI)	The proportion of subjects with a Type 4a MI within 12-24 hours post- PCI.	12-24 hours
Secondary	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.	12-24 hours