Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation

Acute Kidney Injury Clinical Trial

— REPAIR  

Official title:

Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01827891
• Other study ID #: AZ-12
• Status: Active, not recruiting
• Phase: N/A
• First received: March 31, 2013
• Last updated: April 9, 2013
• Start date: March 2012
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: Beijing Anzhen Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 310
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with diabetes undergoing percutaneous coronary intervention were included.

Exclusion Criteria:

1. emergency PCI,

2. baseline troponin value > 0.04 ng/mL,

3. nicorandil or glibenclamide use (preconditioning-mimetic and preconditioning-blocking medication, respectively),

4. patient on dialysis,

5. patients who had some inability to cooperate with the trial,

6. those who could not give informed consent, and (7) second procedure of staged elective PCI in this hospitalization.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Kidney Injury

Intervention

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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital, Capital Medical University	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Anzhen Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	relative reduction in estimated glomerular filtration rate	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.	180 days after procedure	Yes