REPAIR: Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Patients with diabetes undergoing elective percutaneous coronary intervention in Beijing Anzhen Hospital were enrolled, and all the eligible participants were randomized to either remote ischemic preconditioning (RIPC) group or control group. 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. Control participants did not experience this procedure of transient upper-limb ischemia.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: control group Control participants did not experience the procedure of transient upper-limb ischemia. |
|
| Active Comparator: remote ischemic preconditioning (RIPC) group 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. |
Procedure: remote ischemic preconditioning (RIPC)
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.
|
Outcome Measures
Primary Outcome Measures
- acute kidney injury [72 hours after procedure]
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).
Secondary Outcome Measures
- relative reduction in estimated glomerular filtration rate [180 days after procedure]
Secondary endpoints were the relative reduction in estimated glomerular filtration rate (eGFR) as well as all cause mortality, myocardial infarction and stent thrombosis at 30-day and 180-day after procedure.
Eligibility Criteria
Criteria
Inclusion Criteria:
- Patients with diabetes undergoing percutaneous coronary intervention were included.
Exclusion Criteria:
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emergency PCI,
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baseline troponin value > 0.04 ng/mL,
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nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),
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patient on dialysis,
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patients who had some inability to cooperate with the trial,
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those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing Anzhen Hospital, Capital Medical University | Beijing | China | 100029 |
Sponsors and Collaborators
- Beijing Anzhen Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AZ-12