IVUS Guided PCI for CKD to Reduce CI-AKI

Study Overview
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Brief Summary
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Patients with Chronic kidney disease are most vulnerable to contrast induced nephropathy after Percutaneous coronary intervention, intravascular ultrasound guidance can be used to safely guide the procedure to reduce the contrast usage, this randomized trial is design to test the hypothesis that IVUS based ultra-low contrast PCI is feasible and can reduce the contrast induced nephropathy.

Detailed Description
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Prospective, open-label, randomized(1:1), multi-center trial of 320 patients allocated to one of the treatment arms(IVUS-guided ultra-low contrast PCI or angiography-guided PCI). The study population will be composed of patients with renal dysfunction referring for PCI on one to more coronary artery. target lesion must be assessable with IVUS. eGFR will be re-evaluated 48 hours after the procedure. and at 1 month, 3 month, 6 month, 12 month. as well as follow-up for other clinical outcomes unless contra-indicated all patients will receive intravenous hydration 12 hours before and after the procedure. saline infusion at a dose of 1ml/kg/hour. if with reduced ejection fraction or overt heart failure reduce the saline infusion to 0.5ml/kg/hour. the use of sodium bicarbonate and diuretic will be left at the discretion of the operator All procedure will be performed using non-ionic, low osmolar or iso-osmolar, iodine-based contrast media the study groups will be compared according to the intention-to-treat principle. Categorial variables will be compared by Fisher's exact test and continuous variables by students T test. Time-dependent events will be estimated by the Kaplan-Meier method and compared by hazards cox model or log-rank test.

Official Title
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IVUS Based Ultra-low Volume Contrast Media PCI to Reduce Contrast Induced Nephrology in Patient With Chronic Kidney disease-a Multi-center, Open Label, Randomized Trial (IVUS-CKD)

Conditions
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Coronary Artery Disease, Chronic Kidney Diseases

Intervention / Treatment
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* Behavioral: IVUS based ultralow contrast PCI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - age over 18 years coronary artery disease referred for percutaneous intervention, with stent, Drug coated bloon, or bioresorbable stent, of one or more epicardial vessel. target lesion must be assessable by IVUS at baseline and during the procedure. 60ml/min/1.73m2<=Baseline Calculated creatinine clearance >=15ml/min/1.73m2 consent can be obtained and comply with all study procedures. Exclusion Criteria: - Use of >50ml of iodinated agent<72 hours Planned used of iodinated contrast within 72 hours after the index procedure use of other nephrotoxic agents<7 days known allergy to contrast agents unstable or unknown renal function prior to PCI life expectancy less than 1 year

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IVUS based ultra-low contrast PCI<br>IVUS based ultra-low contrast PCI | Behavioral: IVUS based ultralow contrast PCI<br>* IVUS based ultralow contrast PCI<br>|
| No Intervention: Standard of care PCI<br>Guideline directed contrast induced nephropathy provention strategy with standard of care PCI procedure. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-induced acute kidney injury | Evaluate whether IVUS-guided PCI reduces CI-AKI. CI-AKI defined as an increase in serum creatine>=0.5mg /dl from the baseline, within 72 hours after the index procedure(or at discharge) comparison to stand-alone angiography-guided PCI. CI-AKI will be defined as an increase in serum creatinine ≥ 0.3 mg/dl （26.52umol）from the baseline value | within 72 hours after the index procedure (or at discharge). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events and components | cardiovascular death, myocardial infarction and target vessel Revascularization | 1 year | 
| stent thrombosis | stents thrombosis will be defines as the occurrence of definite or probably stent thrombosis according to the ARC criteria | 1 year | 
| serious acute kidney dysfunction | >=2mg /dl increase of serum creatine or need for dialysis | 1 year | 
| procedure time | procedure time from gain access to finish the procedure | 1 day | 
| radiation exposure | total radiation exposure dose | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CKD, IVUS, CAD, PCI