IVUS Guided PCI for CKD to Reduce CI-AKI (IVUS-CKD)

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)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Coronary Artery Disease; Chronic Kidney Diseases
• Intervention / Treatment: Behavioral: IVUS based ultralow contrast PCI

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.

• Study Type: Interventional
• Enrollment (Estimated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mingyou Zhang, PHD; Phone Number: 13689842200; Email: zmy@jlu.edu.cn

Study Locations

• China
  • Jilin
    • Chang chun, Jilin, China, 130000
      • Jilin University
  • Shanghai
    • Shanghai, Shanghai, China
      • Zhongshan Hospital
      • Contact: Chenguang Li, PHD; Phone Number: 13816767665; Email: li.chenguang@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Jilin University
• Collaborators: Shanghai Zhongshan Hospital; First Affiliated Hospital Xi'an Jiaotong University; Zhongnan Hospital; China-Japan Union Hospital, Jilin University; Zhongshan People's Hospital, Guangdong, China; The Sixth People's Hospital of Zhengzhou
• Investigators: Principal Investigator: Mingyou Zhang, Jilin University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 13, 2023
• First Submitted That Met QC Criteria: June 13, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 13, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: PCI; CKD; IVUS; CAD
• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Urologic Diseases; Disease Attributes; Renal Insufficiency; Coronary Disease; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Coronary Artery Disease; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: IVUSCKD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No