An interventional study of Coronary angiography using DyeVert system and Coronary angiography using conventional manual injection syringe. in Contrast-induced Acute Kidney Injury and Acute Coronary Syndromes, sponsored by Clinica Mediterranea. Completed at 2 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-05.
Sponsored by Clinica Mediterranea · Not applicable, Interventional, and Prevention
Among 138 studies in Acute Coronary Syndrome with a site in Italy — 25 open to participants now, 30 under way, 2 of them phase 3. Acute Coronary Syndrome · Italy.
Among the 138 studies in Acute Coronary Syndrome with a site in Italy, this one is the 43rd largest by enrollment of the 85 interventional ones, is one of 4 that started in 2020, is one of 29 with no phase, and was the 96th registered.
1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.
This study's enrollment of 522 is above the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.
Browse Acute Coronary Syndrome studies →25 of the 138 studies in Acute Coronary Syndrome with a site in Italy are open now, in 12 countries. Each count lists the studies.
Of the 196 Acute Coronary Syndrome studies recruiting now, 144 (73%) set no upper age limit and 19 (10%) stop at 75 or younger; 14 take children under 18; 15 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →138 studies; the count open now beside each. This study's row is marked.
First in 2003; this study’s year is marked. 4 started in 2020.
Median enrollment 522 across the 85 interventional studies, 1,000 across the 52 observational. Of the 75 that completed or were terminated, 20 (27%) have results posted.
34 of 138 have an industry lead sponsor. The 10 most frequent:
Clinica Mediterranea is the lead sponsor of 8 studies on the registry; 1 is open to participants now.
Clinica Mediterranea has 1 study filed under Acute Coronary Syndrome — fewer than ten, so there is no comparison to draw.
9 of the studies in Acute Coronary Syndrome with a site in Italy that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07440381Phase 3Heart Care FoundationtriPle Oral thERapy With Bempedoic Acid vs uSual Care in Early Lipid Management of Patients With acUte coronAry synDromE | 2027-08 |
| NCT07588295Maria Cecilia HospitalLocal And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease | 2026-12 |
| NCT01218776University of BolognaInternational Survey of Acute Coronary Syndromes | 2026-12-31 |
| NCT06927739AbcentraFocused Orticumab Research for Treating Inflammation in Coronary Arteries | 2027-02-08 |
| NCT07429227Casa di Cura Dott. PederzoliEvaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status. | 2027-03 |
Among the 138 studies in Acute Coronary Syndrome with a site in Italy, from their registry updates:
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).
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 associated with higher early and late adverse events. It has been emphasized that the pathogenesis of AKI in the setting of ACS is multifactorial, including age, unstable hemodynamic conditions, co-morbidities (that is, diabetes mellitus and anemia) pre-existing chronic kidney disease, dehydration and administration of nephrotoxic drugs. However, the role of iodinated contrast media (CM) has been well established. Hydration represents the cornerstone in contrast-induced AKI (CI-AKI) prevention. However, at present there is no consensus on how hydration should be carried out, especially in ACS patients, and all the the recommended hydration regimens have limited applicability in the urgent/emergent settings such as ACS. Several targeted hydration regimens have been proposed, but none has been tested in ACS patients; in the present trial the investigators will adopt the left ventricular end diastolic pressure (LVEDP) -guided hydration because this approach is simple and easy to implement in the current target population. The CM volume used is an independent predictor of CI-AKI and the concept that "the lower the CM volume, the lower the CI-AKI risk" is generally accepted. The administration of a CM volume >3X glomerular filtration rate (GFR) is suggestive of increased risk of CI-AKI. To date the use of manual injections with a manifold remains the preferred technique in the majority of catheterization laboratories. In particular, manual injection is often favored for interventional procedures, which require low, variable-flow pressure injections. The AVERT trial demonstrated that CM volume is significantly lower in patients randomized to DyeVert™ in comparison to control (36.9 ± 10.9 mL versus 62.5 ± 12.7 mL, p \< 0.001) and the observed reduction in CM volume used was most evident in patients undergoing PCI. Therefore, in this scenario is of outmost importance to limit the CM volume in the attempt to prevent CI-AKI. 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 or immediate (within 2 hours) invasive diagnostic and/or interventional cardiovascular procedures.
METHODS All patients with ACS scheduled for urgent/immediate coronary angiography/angioplasty will be screened for inclusion/exclusion criteria. Diagnosis of ACS (both ST-Elevation Myocardial Infarction [STEMI] and high-risk Non-ST-Elevation Myocardial Infarction [Non-STEMI]) will be established in accordance with guidelines, including a typical chest pain history, diagnostic electrocardiographic changes, and serial increase of cardiac biomarkers. All patients with inclusion/exclusion criteria satisfied and who will agree to sign the informed consent will be enrolled into the trial. The REMEDIAL IV trial will be conducted at a pool of Italian interventional cardiology centers, according to the principles of the Declaration of Helsinki and Good Clinical Practice and has been approved by the local Ethic Committees.
All the patients included into the study will receive intravenous 0.9% sodium chloride as soon as in the catheterization laboratory; the hydration regimen will be defined according to the hemodynamic conditions, as defined below. The patients will be then randomized into 2 groups: 1) DyeVert group, and 2) Control group.
STUDY ENDPOINTS The primary endpoint of the trial is the rate of CI-AKI. CI-AKI is defined as an increase in the serum creatinine (sCr) concentration ≥ 0.3 mg/dL from the baseline value within 5 days after CM administration or the need for dialysis. Secondary end-points will include: 1) differences in the CM volume in the 2 groups; 2) an increase in the sCr concentration ≥25% within 5 days after CM exposure; 4) the severity of AKI assessed according to the Acute Kidney Injury Network criteria: Stage 1, a sCr increase ≥0.3 mg/dL or ≥1.5-1.9 times from baseline; Stage 2, a sCr increase ≥2.0-2.9 times from baseline; and Stage 3, a sCr increase ≥3.0 times from baseline or the need for dialysis; 5) changes in the serum cystatin C concentration at 24 and 48 hours after CM exposure; 6) the rate of acute renal failure requiring dialysis (defined as a decrease in renal function necessitating acute hemodialysis, ultrafiltration or peritoneal dialysis within the first 5 days post-intervention); 7) the rate of in-hospital, 6 and 12-month major adverse events (MAE), including death, renal failure requiring dialysis, acute pulmonary edema, and sustained kidney injury. Sustained kidney injury is defined as a persistent ≥25% GFR reduction compared to baseline at 6 and 12 months; and 8) the length in in-hospital stay, calculated as the sum of the number of days since admission until discharge from the hospital.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
ST-Elevation Myocardial Infarction (according to Fourth Universal Definition of Myocardial Infarction);
High-risk Non-ST-Elevation Myocardial Infarction (according to current guidelines):
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive intravenous 0.9% sodium chloride as soon as in the catheterization laboratory. The hydration regimen will be defined according to the hemodynamic conditions and modulated according to the left ventricular end diastolic pressure (LVEDP). During the PCI the CM injection will be handled by the DyeVert TM system.
Device: Coronary angiography using DyeVert system
Patients will receive intravenous 0.9% sodium chloride as soon as in the catheterization laboratory. The hydration regimen will be defined according to the hemodynamic conditions and modulated according to the left ventricular end diastolic pressure (LVEDP). During the PCI the CM injection will be carried out by a conventional manual injection syringe. Strategies for limiting CM volume are: 1. angiograms will be performed with injection of contrast using a 3-cm 3 syringe; this provides strict control of CM delivery by limiting the volume of contrast that can be administered in a single injection; 2. catheters with sideholes will be strictly avoided during percutaneous intervention; 3. when exchanging catheters, unused contrast is withdrawn from the catheter lumen (e.g., by back-bleeding through an opened ''Y''-connector or by aspirating residual contrast from the catheter using a syringe) 4. ''tests'' with ''puffs'' of CM are discouraged.
Procedure: Coronary angiography using conventional manual injection syringe.
Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using DyeVert system.
Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using conventional manual injection syringe.
Rate of contrast-induced Acute Kidney Injury (CI-AKI).
Serum creatinine (mg(dL) is assessed at baseline (before coronary intervention) and then every day during the hospital stay. CI-AKI is defined as a change in the serum creatinine concentration ≥0.3 mg/dL from the baseline value within 5 days after contrast media administration or the need for dialysis.
Time frame: 30 days
Differences in the contrast media volume in the 2 groups.
Volume of contrast media utilized (mL) is assessed in all enrolled patients at the end of the procedure
Time frame: 30 days
Change in the sCr concentration ≥ 25 percent within 5 days after CM exposure.
Serum creatinine (mg(dL) is assessed at baseline at baseline (before coronary intervention) and therefore every day during the hospidal stay
Time frame: 30 days
Severity of AKI assessed according to the Acute Kidney Injury Network criteria.
Stage 1, a sCr change ≥0.3 mg/dL or ≥1.5-1.9 times from baseline; Stage 2, a sCr change ≥2.0-2.9 times from baseline; Stage 3, a sCr change ≥3.0 times from baseline or the need for dialysis.
Time frame: 30 days
Changes in the serum cystatin C concentration at 24 and 48 hours after CM exposure.
Serum Cystatin C (mg/dL) is assessed at baseline (before the coronary procedure) and at 24 and 48 hours after the procedure
Time frame: 48 hours
Rate of acute renal failure requiring dialysis.
Change in renal function necessitating acute hemodialysis, ultrafiltration or peritoneal dialysis within the first 5 days post intervention.
Time frame: 5 days
Rate of in-hospital, 6 and 12 month major adverse events (MAE).
MAE include death, renal failure requiring dialysis, acute pulmonary edema, and sustained kidney injury (defined as a persistent ≥25% GFR change compared to baseline at 6 and 12 months
Time frame: 12 months
Length of in-hospital stay.
In-hospital stay calculated as the sum of the number of days since admission until discharge from the hospital.
Time frame: 30 days
Ran from Feb 2020 to primary completion in Dec 2022, 34 months.
Of 210 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's 34 months is close to that.
Counting every sponsor, half of 225 studies reached it within 34 months; a quarter within 18 and three quarters within 46.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Clinica Mediterranea