NCT04936607 ImproviNg rEnal Outcomes Following Coronary angiograPhy and/or percuTaneoUs coroNary intErventions
| NCT ID | NCT04936607 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montreal Heart Institute |
| Condition | Contrast-Induced Acute Kidney Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,158 participants |
| Start Date | 2021-06-28 |
| Primary Completion | 2027-01-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 1,158 participants in total. It began in 2021-06-28 with a primary completion date of 2027-01-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The NEPTUNE triple-blind, active-placebo, adaptive, pragmatic, randomized trial aims to evaluate the effectiveness of a new intra-venous hydration strategy guided by left ventricular end-diastolic pressure (LVEDP), amount of contrast used, and baseline renal function, to prevent contrast-induced acute kidney injury (CI-AKI) and patient-oriented clinical endpoints in all-comer patients undergoing coronary angiogram and/or percutaneous coronary intervention (PCI).
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years; * Planned coronary angiogram and/or PCI; * Willingness to participate and to attend study visits; * Expected life expectancy ≥6 months. Exclusion Criteria: * Cardiogenic or non-cardiogenic shock at the time of the procedure; * Emergent procedures (e.g. STEMI); * Iodine-based contrast media received within 2 days; * Presence of Intra-Aortic Balloon Pump (IABP); * Cardiac arrest within 24 hours; * Pre-procedural AKI defined using the modified KDIGO criteria within 7 days; * Renal replacement therapy; * Severe aortic or mitral disease; * LVEF \<30%.
Contact & Investigator
Guillaume Marquis-Gravel, MD, MSc
PRINCIPAL INVESTIGATOR
Montreal Heart Institute
Frequently Asked Questions
Who can join the NCT04936607 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Contrast-Induced Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04936607 currently recruiting?
Yes, NCT04936607 is actively recruiting participants. Contact the research team at guillaume.marquis.gravel@umontreal.ca for enrollment information.
Where is the NCT04936607 trial being conducted?
This trial is being conducted at Montreal, Canada.
Who is sponsoring the NCT04936607 clinical trial?
NCT04936607 is sponsored by Montreal Heart Institute. The principal investigator is Guillaume Marquis-Gravel, MD, MSc at Montreal Heart Institute. The trial plans to enroll 1,158 participants.
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