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

June 13, 2023 updated by: Mingyou Zhang, Jilin University

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: within 72 hours after the index procedure (or at discharge).

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
Time Frame: 1 year
cardiovascular death, myocardial infarction and target vessel Revascularization
1 year
stent thrombosis
Time Frame: 1 year
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
Time Frame: 1 year

>=2mg

/dl increase of serum creatine or need for dialysis
1 year
procedure time
Time Frame: 1 day
procedure time from gain access to finish the procedure
1 day
radiation exposure
Time Frame: 1 day
total radiation exposure dose
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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