IVUS Guided PCI for CKD to Reduce CI-AKI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-10-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Disease Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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IVUS based ultra-low contrast PCI

Group Type EXPERIMENTAL

IVUS based ultralow contrast PCI

Intervention Type BEHAVIORAL

IVUS based ultralow contrast PCI

Standard of care PCI

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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IVUS based ultralow contrast PCI

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No