Using ultrasound to guide heart procedures in patients with kidney disease
" Contrast-free " IVUS Guided PCI Compared to Standard Angio-guided PCI in Patient With sEvere kidnEy Disease
This study is testing whether using ultrasound to guide heart procedures can help people with kidney disease avoid serious complications from traditional methods that use contrast dye.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 2 sites (Créteil, Creteil and 1 other locations) |
| Trial ID | NCT06813534 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of an intravascular ultrasound (IVUS)-guided approach for performing percutaneous coronary interventions (PCI) in patients suffering from chronic kidney disease (CKD). The focus is on reducing the incidence of contrast-induced nephropathy (CIN), a serious complication that can arise from traditional PCI methods that require iodine contrast. By utilizing a 'zero-contrast' strategy, the study seeks to demonstrate that IVUS can safely guide these procedures without the associated risks of contrast agents. The primary outcome will be the incidence of CIN within 72 hours post-procedure.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with chronic kidney disease and a creatinine clearance of 30 mL/min or less who require a PCI.
Not a fit: Patients who have undergone iodine contrast injection in the previous 72 hours or those on permanent dialysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of kidney damage in patients with chronic kidney disease undergoing heart procedures.
How similar studies have performed: While many studies have explored pharmacological strategies to prevent CIN, the use of IVUS as a per-procedural strategy in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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"
Where this trial is running
Créteil, Creteil and 1 other locations
- Romain GALLET — Créteil, Creteil, France (Not_yet_recruiting)
- Romain GALLET — Créteil, France (Recruiting)
Study contacts
- Study coordinator: Romain GALLET, Pr
- Email: romain.gallet@aphp.fr
- Phone: 01 49 81 21 11
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.