IVUS Guided PCI for CKD to Reduce CI-AKI

Coronary Artery Disease Clinical Trial

— IVUS-CKD  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05913362
• Other study ID #: IVUSCKD
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2023
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2023
• Source: Jilin University
• Contact: Mingyou Zhang, PHD
• Phone: 13689842200
• Email: zmy[@]jlu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 320
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Coronary Artery Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Behavioral:
• IVUS based ultralow contrast PCI
IVUS based ultralow contrast PCI

Locations

Country	Name	City	State
China	Jilin university	Chang chun	Jilin
China	Zhongshan Hospital	Shanghai	Shanghai

Sponsors (7)

Lead Sponsor	Collaborator
Jilin University	China-Japan Union Hospital, Jilin University, First Affiliated Hospital Xi'an Jiaotong University, Shanghai Zhongshan Hospital, The Sixth People's Hospital of Zhengzhou, Zhongnan Hospital, Zhongshan People's Hospital, Guangdong, China

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

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