Remote Ischemic Conditioning Using the autoRIC (SHIELD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03318575|
Recruitment Status : Recruiting
First Posted : October 24, 2017
Last Update Posted : July 17, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ischemia-Reperfusion Injury||Device: autoRIC Device: autoRIC Sham||Not Applicable|
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 elective PCI.
Eligible patients that are scheduled for an elective 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Safety and Effectiveness of Remote Ischemic Conditioning With the autoRIC Prior to Elective Percutaneous Coronary Intervention (PCI) Study|
|Actual Study Start Date :||January 30, 2018|
|Estimated Primary Completion Date :||November 2018|
|Estimated Study Completion Date :||November 2018|
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.
Device: autoRIC Sham
Automated Remote Ischemic Conditioning Sham
- (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 at or 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318575
|Contact: Vera Belaoussoff||647-722-9601 ext firstname.lastname@example.org|
|Contact: Brad Solbergemail@example.com|
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: Patrick Frazier, RN 205-934-5774 CCTU@uabmc.edu|
|Principal Investigator: Massoud Leesar, MD|
|United States, Florida|
|University of Florida Health Jacksonville||Recruiting|
|Jacksonville, Florida, United States, 32209|
|Contact: Emily Green, BSN, RN 904-244-2794 firstname.lastname@example.org|
|Principal Investigator: Andres Pineda Maldonado, MD|
|United States, Iowa|
|Iowa Heart Center||Recruiting|
|Des Moines, Iowa, United States, 50314|
|Contact: Kassandra Seitz, BSN, RN 515-235-5114 email@example.com|
|Principal Investigator: Magdi Ghali, MD|
|United States, Michigan|
|Henry Ford Hospital||Recruiting|
|Detroit, Michigan, United States, 48202|
|Contact: Margaret Fox, RN, BSN 313-916-1879 firstname.lastname@example.org|
|Principal Investigator: Gerald Koenig, MD, PhD|
|United States, Missouri|
|Saint Luke's Hospital of Kansas City||Recruiting|
|Kansas City, Missouri, United States, 64111|
|Contact: Lisa Lacy, RCIS 816-932-7528 email@example.com|
|Principal Investigator: John Saxon, MD|
|United States, North Carolina|
|Novant Health Heart and Vascular Institute||Recruiting|
|Charlotte, North Carolina, United States, 28204|
|Contact: Pailing Richards, RN, BSN 704-264-1400 firstname.lastname@example.org|
|Principal Investigator: Amjad Almahameed, MD|
|NC Heart and Vascular Research||Recruiting|
|Raleigh, North Carolina, United States, 27607|
|Contact: James R Pierre-Louis, MD, CRS 919-784-7695 email@example.com|
|Principal Investigator: Mohit Pasi, MD|
|Principal Investigator:||Roxana Mehran, MD||Cardiovascular Medicine Associates|