Status:
COMPLETED
DyeVert System and Contrast-induced Acute Kidney Injury
Lead Sponsor:
Clinica Mediterranea
Conditions:
Contrast-induced Acute Kidney Injury
Acute Coronary Syndromes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
Acute kidney injury (AKI) is a common complication in patients suffering from acute coronary syndromes (ACS) and treated by percutaneous coronary intervention (PCI). This complication has been associa...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Women who are pregnant.
- Recent contrast media exposure: contrast media exposure within 48 hours.
- End-stage chronic kidney disease on chronic dialysis: both haemodialysis and peritoneal dialysis.
- Multiple myeloma.
- Current enrolment in any other study when enrolment in the REMEDIAL IV would involve deviation from either protocol.
Key Trial Info
Start Date :
February 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
522 Patients enrolled
Trial Details
Trial ID
NCT04714736
Start Date
February 10 2020
End Date
December 31 2023
Last Update
March 5 2024
Active Locations (2)
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1
IRCCS Policlinico Multimedica
Milan, Italy, 20142
2
Clinica Mediterranea
Naples, Italy, 80121