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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2013 by Beijing Anzhen Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Yujie Zhou, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier:
NCT01827891
First received: March 31, 2013
Last updated: April 9, 2013
Last verified: April 2013
  Purpose
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 Intervention
Acute Kidney Injury
Procedure: remote ischemic preconditioning (RIPC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Remote Ischemic Preconditioning and Risk of Contrast-Induced Acute Kidney Injury in Patients Undergoing Coronary Stent Implantation

Further study details as provided by Beijing Anzhen Hospital:

Primary Outcome Measures:
  • acute kidney injury [ Time Frame: 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 [ Time Frame: 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.


Enrollment: 310
Study Start Date: March 2012
Estimated Study Completion Date: June 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01827891

Locations
China
Beijing Anzhen Hospital, Capital Medical University
Beijing, China, 100029
Sponsors and Collaborators
Beijing Anzhen Hospital
  More Information

Responsible Party: Yujie Zhou, professor of cardiology, Vice president of Beijing Anzhen Hospital, Beijing Anzhen Hospital
ClinicalTrials.gov Identifier: NCT01827891     History of Changes
Other Study ID Numbers: AZ-12
Study First Received: March 31, 2013
Last Updated: April 9, 2013

Keywords provided by Beijing Anzhen Hospital:
acute kidney injury
percutaneous coronary intervention
remote ischemic preconditioning

Additional relevant MeSH terms:
Wounds and Injuries
Acute Kidney Injury
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on March 24, 2017