NCT04714736Completed
DyeVert System and Contrast-induced Acute Kidney Injury
Renal Insufficiency Following Contrast Media Administration Trial IV: Contrast Media Volume Control for Limiting Contrast-Induced Acute Kidney in Acute Coronary Syndrome.
Source: ClinicalTrials.gov · Last updated 5 Mar 2024
Brief summary (registry, in English)
The aim of the REnal Insufficiency Following Contrast MEDIA Administration TriaL IV (REMEDIAL IV) is to test whether the use of the DyeVert system is effective in reducing CI-AKI rate in ACS patients undergoing urgent/immediate (within 2 hours) invasive diagnostic and/or interventional cardiovascular procedures. The DyeVert™ system (Osprey Medical Inc., Minnetonka, MN, USA) is a novel device designed to reduce CM volume during coronary procedures, while maintaining fluoroscopic image quality. Patients with ACS scheduled for urgent/immediate coronary angiography/angioplasty will be enrolled and randomized into 2 groups: 1) DyeVert group (CM injection will be handled by the DyeVert TM system), and 2) Control group (CM injection will be carried out by a conventional manual injection syringe).
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 522 (actual)
- First submitted
- 10 Jan 2021
- Start date
- 10 Feb 2020
- Primary completion date
- 31 Dec 2022
- Lead sponsor
- Clinica Mediterranea
- Diseases
- Coronary artery disease
- NCT number
- NCT04714736
What you commit to
- Study type: Interventional
- Participants enrolled: 522
- From 10 Feb 2020 to the primary completion date, 31 Dec 2022
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- End-stage chronic kidney disease on chronic dialysis: both haemodialysis and peritoneal dialysis.
Other
- Women who are pregnant.
- Recent contrast media exposure: contrast media exposure within 48 hours.
- Multiple myeloma.
- Current enrolment in any other study when enrolment in the REMEDIAL IV would involve deviation from either protocol.
Who the study is looking for
- Urgent or immediate (within 2 hours) coronary procedure with iodinated contrast media administration in the setting of an acute coronary syndrome:
- ST-Elevation Myocardial Infarction (according to Fourth Universal Definition of Myocardial Infarction);
- High-risk Non-ST-Elevation Myocardial Infarction (according to current guidelines):
- Refractory angina,
- Signs or symptoms of heart faiklure or new or worsening mitral regurgitation,
- Hemodynamic instability,
- Recurrent angina or ischemia at rest or with low-level activities despite intensive medical therapy,
- Sustained ventricular tachycardia or ventricular fibrillation,
- Recurrent dynamic ST-T wave changes, particularly with intermittent ST-elevation.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Policlinico Multimedica Coordinator of this site? Confirm its status | Milan | Italy | Unknown status |
| Clinica Mediterranea Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.