Single-cycle Remote Ischemic Preconditioning and Postconditioning for Prevention of Contrast-Induced Nephropathy

Study Overview
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Brief Summary
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This trial is a 2 x 2 factorial design, double-blinded, randomized controlled trial to evaluate efficacy and safety of remote ischemic preconditioning and postconditioning for prevention of contrast-induced acute kidney injury in patient undergoing coronary angiography and angioplasty

Detailed Description
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randomized controlled trial

Official Title
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Efficacy of Single-cycle Remote Ischemic Pre/Post-conditioning, for Prevention of Contrast-induced Acute Kidney Injury in Patients With Chronic Kidney Disease Undergoing Coronary Angiography or Coronary Angioplasty

Conditions
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Ischemic Reperfusion Injury

Intervention / Treatment
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* Procedure: RIPre
* Procedure: RIPost
* Procedure: Sham-Pre
* Procedure: Sham-Post


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient have indication for coronary angiography or angioplasty. Impaired renal function with reduced eGFR < 60 ml/min/1.73 m2 by CKD-EPI equation. Written informed consent. Exclusion Criteria: History of contrast allergy. The patient had end-stage renal failure with the need for hemodialysis. The patient take medications that affect the kidneys function within 48 hours before study. The patient had acute kidney injury from any cause. The patient was received contrast media within 2 weeks before study. The patient had cardiac arrest or shock. The patient had peripheral arterial disease (PAD) Pregnancy Refused to study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RIPre + RIPost<br>Intervention: RIPre 200 mmHg + RIPost 200 mmHg | Procedure: RIPre<br>* Preconditioning 200 mmHg x 5 minutes before procedure<br>Procedure: RIPost<br>* Postconditioning 200 mmHg x 5 minutes after procedure<br>|
| Experimental: RIPre + Sham<br>Intervention: RIPre 200 mmHg + Sham 10 mmHg | Procedure: RIPre<br>* Preconditioning 200 mmHg x 5 minutes before procedure<br>Procedure: Sham-Post<br>* Sham 10 mmHg x 5 minutes after procedure<br>|
| Experimental: Sham + RIPost<br>Intervention: Sham 10 mmHg + RIPost 200 mmHg | Procedure: RIPost<br>* Postconditioning 200 mmHg x 5 minutes after procedure<br>Procedure: Sham-Pre<br>* Sham 10 mmHg x 5 minutes before procedure<br>|
| Sham Comparator: Sham + Sham<br>Intervention: Sham 10 mmHg + Sham 10 mmHg | Procedure: Sham-Pre<br>* Sham 10 mmHg x 5 minutes before procedure<br>Procedure: Sham-Post<br>* Sham 10 mmHg x 5 minutes after procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value |  | Within a period of 24 hours after contrast medium administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sCr and eGFR from baseline |  | Within a period of 24 hours after contrast medium administration | 
| Major adverse cerebrovascular and cardiovascular events (MACCE) in each intervention group | MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack | Within a period of 6 months after contrast medium administration | 
| Incidence(%) of CI-AKI in differrent subgroups of patient characteristics | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value. | Within a period of 24 hours after contrast medium administration | 
| Incidence(%) of CI-AKI in patients with vs without RIPre and RIPost | Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value | Within a period of 24 hours after contrast medium administration | 
| Incidence(%) of MACCE in differrent subgroups of patient characteristics | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack | Within a period of 6 months after contrast medium administration | 
| Incidence(%) of MACCE in patients with vs without RIPre and RIPost | Patient characteristics include eGFR, global CIAKI risk score, contrast media volume and DM. MACCE were composite of death, hospitalization, acute coronary syndrome, congestive heart failure and stroke or transient ischemic attack | Within a period of 6 months after contrast medium administration | 
| Incidence(%) of MACCE in patients who have CI-AKI vs patients who have no CI-AKI | Incidence of CI-AKI, which was defined as an increment of serum creatinine 0.5 mg/dL or a relative increase of 25% over the baseline value within a period of 24 hours after contrast medium administration | Within a period of 6 months after contrast medium administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischemic Preconditioning, Postconditioning, Angioplasty, Angiography, Contrast-Induced Nephropathy