Clinical trial NCT05913362: IVUS Guided PCI for CKD to Reduce CI-AKI
Official title: 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)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Chronic Kidney Diseases
Keywords: CKD
IVUS
CAD
PCI
Lead sponsor: Jilin University
Sponsor class: OTHER
Collaborators: name: Shanghai Zhongshan Hospital
name: Zhongnan Hospital
name: Zhongshan People's Hospital, Guangdong, China
name: The Sixth People's Hospital of Zhengzhou
name: China-Japan Union Hospital, Jilin University
name: First Affiliated Hospital Xi'an Jiaotong University
First posted: 2023-06-22
Enrollment: 320
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Contrast-induced acute kidney injury
timeFrame: within 72 hours after the index procedure (or at discharge).
Secondary outcomes:
measure: Major adverse cardiac events and components
timeFrame: 1 year
measure: stent thrombosis
timeFrame: 1 year
measure: serious acute kidney dysfunction
timeFrame: 1 year
measure: procedure time
timeFrame: 1 day
measure: radiation exposure
timeFrame: 1 day
Other outcomes:
Locations:
city: Chang chun
country: China
facility: Jilin university
state: Jilin
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
affiliation: Jilin University
name: Mingyou Zhang
role: PRINCIPAL_INVESTIGATOR
References:
citation: McCullough PA, Choi JP, Feghali GA, Schussler JM, Stoler RM, Vallabahn RC, Mehta A. Contrast-Induced Acute Kidney Injury. J Am Coll Cardiol. 2016 Sep 27;68(13):1465-1473. doi: 10.1016/j.jacc.2016.05.099.
citation: Rudnick MR, Leonberg-Yoo AK, Litt HI, Cohen RM, Hilton S, Reese PP. The Controversy of Contrast-Induced Nephropathy With Intravenous Contrast: What Is the Risk? Am J Kidney Dis. 2020 Jan;75(1):105-113. doi: 10.1053/j.ajkd.2019.05.022. Epub 2019 Aug 28.
citation: Mariani J Jr, Guedes C, Soares P, Zalc S, Campos CM, Lopes AC, Spadaro AG, Perin MA, Filho AE, Takimura CK, Ribeiro E, Kalil-Filho R, Edelman ER, Serruys PW, Lemos PA. Intravascular ultrasound guidance to minimize the use of iodine contrast in percutaneous coronary intervention: the MOZART (Minimizing cOntrast utiliZation With IVUS Guidance in coRonary angioplasTy) randomized controlled trial. JACC Cardiovasc Interv. 2014 Nov;7(11):1287-93. doi: 10.1016/j.jcin.2014.05.024. Epub 2014 Oct 15.