IVUS Guided PCI in Patients With Chronic Kidney Disease (SPEED)

February 3, 2025 updated by: Assistance Publique - Hôpitaux de Paris

" Contrast-free " IVUS Guided PCI Compared to Standard Angio-guided PCI in Patient With sEvere kidnEy Disease

The incidence of contrast-induced nephropathy (CIN) is high (> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure.

The development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk.

Intracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast.

The main objective is to show that an IVUS-guided "zero-contrast" coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The incidence of contrast-induced nephropathy (CIN) is high (> 25%) in patients with severe chronic renal disease (CKD) who undergo a percutaneous coronary procedure.

The development of CIN is a factor of poor prognosis and is associated with the occurrence of irreversible CKD, the need for dialysis, increased length of stay and hospital costs as well as the risk of death. There is no specific treatment for N-PCI, so its prevention is essential. Although many studies have been conducted to identify, compare and implement different pharmacological strategies for the prevention of CIN before percutaneous coronary procedurse, few per-procedural strategies have been studied to prevent this risk.

Intracoronary ultrasound (IVUS) is an essential tool, used routinely to guide percutaneous coronary procedures thanks to ultrasound, it does not require the injection of iodine contrast.

The main objective is to show that an IVUS-guided "zero-contrast" coronary angioplasty strategy in patients with severe renal impairment decreases the incidence of CIN within 72 hours of procedure.

Study Type

Interventional

Enrollment (Estimated)

170

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

Study Locations

  • France
      • Créteil, France, 94010
    • Creteil
      • Créteil, Creteil, France, 94010
        • Not yet recruiting
        • Romain GALLET
        • Contact:

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:

  • Patients over 18 years old
  • Indication for PCI
  • Chronic kidney disease with creatinine clearance ≤ 30 mL/min/1.73m²
  • Feasibility of IVUS determined by 2 trained interventional cardiologist
  • Affiliated to social security

Exclusion Criteria:

  • Iodine contrast injection in the previous 72 hours
  • Known allergy to iodine contrast
  • Permanent dialysis
  • Chronic total occlusion
  • Hemodynamic instability
  • Legal protection
  • Pregnant of breastfeeding patients
  • Patients on "AME"

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Conventionnal PCI
Contrast guided PCI
Device: Intravascular Ultrasound guided PCI
Intra-coronary ultrasound
Experimental: IVUS guided PCI
IVUS guided PCI with iodine contrast injection limited (as much as possible) to a final control injection.
Device: Intravascular Ultrasound guided PCI
Intra-coronary ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of serum creatinine due to nephropathy
Time Frame: 30 days
Contrast-induced nephropathy is defined as an increase in creatininemia by 25% from its baseline level. The parameter being measured is creatininemia, which refers to the concentration of creatinine in the blood. The unit of measurement for this increase is a percentage (%)
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global safety
Time Frame: 30 days
The occurrence of death from any cause within 30 days. The unit of measurement is the presence or absence of death.
30 days
Endocoronary complications
Time Frame: 72 hours
his includes dissection, thrombus formation, breaches, or coronary occlusion that require an additional unplanned intervention. The unit of measurement is the occurrence of these complications, recorded as Yes or No.
72 hours
Procedural Criteria
Time Frame: 72 hours
Procedure time: The total time taken for the procedure. The unit of measurement is time, typically recorded in minutes (min)
72 hours
Myocardial infarction
Time Frame: 30 days
The occurrence of a myocardial infarction within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No."
30 days
Global safety : stroke
Time Frame: 30 days
Stroke: The occurrence of a stroke within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No
30 days
Global safety
Time Frame: 30 days
Unplanned hospitalization for cardiac or renal causes: The occurrence of an unplanned hospitalization due to cardiac or renal causes within 30 days. The unit of measurement is the presence or absence of the event, recorded as Yes or No.
30 days
Angioplasty failures
Time Frame: 72 hours
Angioplasty failures are defined by a residual stenosis of 70% or greater and/or a TIMI flow of less than 3 at the end of the procedure. The unit of measurement for residual stenosis is percentage (%) and for TIMI flow, the unit is a scale from 0 to 3, with a TIMI flow of less than 3 indicating failure.
72 hours
Procedural Criteria : Fluoroscopy time
Time Frame: 72 hours
Fluoroscopy time: The amount of time fluoroscopy imaging is used during the procedure. The unit of measurement is time, typically recorded in minutes (min)
72 hours
Procedural Criteria: Air Kerma
Time Frame: 72 hours
Air Kerma: A measure of the radiation dose delivered during the procedure. The unit of measurement is the Gray (Gy), specifically milligray (mGy) for this context
72 hours
Procedural Criteria : PDS (Procedure Dose Score)
Time Frame: 72 hours
PDS (Procedure Dose Score): A measure of the total radiation dose delivered to the patient during the procedure. The unit of measurement is arbitrary units based on the specific scoring system used.
72 hours
Procedural Criteria
Time Frame: 72 hours
Volume of contrast injected: The amount of contrast material used during the procedure. The unit of measurement is milliliters (mL)
72 hours

Collaborators and Investigators

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

Sponsor

Assistance Publique - Hôpitaux de Paris

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 (Actual)

August 8, 2024

Primary Completion (Estimated)

July 7, 2027

Study Completion (Estimated)

August 4, 2027

Study Registration Dates

First Submitted

May 9, 2023

First Submitted That Met QC Criteria

February 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 3, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP230196

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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