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NCT Number: NCT06813534

IVUS Guided PCI in Patients With Chronic 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Romain GALLET, Créteil, Creteil, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Intravascular Ultrasound guided PCI

Device

Intra-coronary ultrasound

Primary outcomes

  1. 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 (%)

Secondary outcomes

  1. 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.

  2. 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.

  3. 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)

  4. 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."

  5. 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

  6. 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.

  7. 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.

  8. 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)

  9. 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

  10. 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.

  11. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Romain GALLET, Pr

CONTACT

[email protected]

01 49 81 21 11

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: SPEED

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2025
Registry last updated
Feb 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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