IVUS Guided PCI for CKD to Reduce CI-AKI

NCT05913362 | Unknown DMC

• 1 other identifier: IVUSCKD
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease; Chronic Kidney Diseases

Keywords

CKD; IVUS; CAD; PCI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Major adverse cardiac events and components

  1 year

• stent thrombosis

  1 year

• serious acute kidney dysfunction

  1 year

• procedure time

  1 day

• radiation exposure

  1 day

Study Arms (2)

IVUS based ultra-low contrast PCI

EXPERIMENTAL

IVUS based ultra-low contrast PCI

Behavioral: IVUS based ultralow contrast PCI

Standard of care PCI

NO INTERVENTION

Guideline directed contrast induced nephropathy provention strategy with standard of care PCI procedure.

Interventions

IVUS based ultralow contrast PCI BEHAVIORAL

IVUS based ultralow contrast PCI

IVUS based ultra-low contrast PCI

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Jilin University: lead
• Shanghai Zhongshan Hospital: collaborator
• Zhongnan Hospital: collaborator
• Zhongshan People's Hospital, Guangdong, China: collaborator
• The Sixth People's Hospital of Zhengzhou: collaborator
• China-Japan Union Hospital, Jilin University: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator

Study Sites (2)

Jilin university

Changchun, Jilin, 130000, China

Location

Zhongshan Hospital

Shanghai, Shanghai Municipality, China

Location

Related Publications (3)

• 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.

  PMID: 27659469 BACKGROUND

• 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.

  PMID: 31473019 BACKGROUND

• 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.

  PMID: 25326742 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mingyou Zhang

  Jilin University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mingyou Zhang, PHD

CONTACT

13689842200; zmy@jlu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate prof

Study Record Dates

• First Submitted: June 13, 2023
• First Posted: June 22, 2023
• Study Start: October 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2025
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)