Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
REPAIR
1 other identifier
interventional
310
1 country
1
Brief Summary
This single-center, randomized controlled trial is to investigate the impact of remote ischemic preconditioning (RIPC) on the risk contrast-induced acute kidney injury and its long-term impact on renal function for patients with diabetes undergoing percutaneous coronary intervention.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 31, 2013
CompletedFirst Posted
Study publicly available on registry
April 10, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedApril 10, 2013
April 1, 2013
10 months
March 31, 2013
April 9, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
acute kidney injury
The primary study endpoint was AKI, defined as an absolute rise in serum creatinine of ≥ 0.5 mg/dl or a relative increase of ≥ 25% compared to baseline within 72 hours from PCI (the maximal measured concentration of serum creatinine during these 72 hours was used).
72 hours after procedure
Secondary Outcomes (1)
relative reduction in estimated glomerular filtration rate
180 days after procedure
Study Arms (2)
control group
PLACEBO COMPARATORControl participants did not experience the procedure of transient upper-limb ischemia.
remote ischemic preconditioning (RIPC) group
ACTIVE COMPARATORThose randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at \< 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.
Interventions
Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at \< 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.
Eligibility Criteria
You may qualify if:
- Patients with diabetes undergoing percutaneous coronary intervention were included.
You may not qualify if:
- emergency PCI,
- baseline troponin value \> 0.04 ng/mL,
- nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
- patient on dialysis,
- patients who had some inability to cooperate with the trial,
- those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Anzhen Hospital, Capital Medical University
Beijing, 100029, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of cardiology, Vice president of Beijing Anzhen Hospital
Study Record Dates
First Submitted
March 31, 2013
First Posted
April 10, 2013
Study Start
March 1, 2012
Primary Completion
January 1, 2013
Study Completion
June 1, 2013
Last Updated
April 10, 2013
Record last verified: 2013-04