Coronary Artery Disease
Conditions
Keywords
Coronary artery disease, chronic kidney disease, Contrast induced nephropathy, IVUS
Brief summary
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.
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.
Interventions
DEVICEIntravascular Ultrasound guided PCI
Intra-coronary ultrasound
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Intervention model description
Participants are assigned to one of two or more groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of serum creatinine due to nephropathy | 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
| Measure | Time frame | Description |
|---|---|---|
| Endocoronary complications | 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. |
| Procedural Criteria | 72 hours | Procedure time: The total time taken for the procedure. The unit of measurement is time, typically recorded in minutes (min) |
| Myocardial infarction | 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. |
| Global safety : stroke | 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 |
| Global safety | 30 days | The occurrence of death from any cause within 30 days. The unit of measurement is the presence or absence of death. |
| Procedural Criteria : Fluoroscopy time | 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) |
| Procedural Criteria: Air Kerma | 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 |
| Procedural Criteria : PDS (Procedure Dose Score) | 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. |
| Angioplasty failures | 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. |
Countries
France
Contacts
Primary ContactRomain GALLET, Pr
Outcome results
None listed