Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:35 PM
Ignite Modification Date:
2025-12-24 @ 7:35 PM
NCT ID:
NCT02980003
Eligibility Criteria:
Inclusion Criteria:
* Consecutive patients scheduled for coronary angiography and/or angioplasty;
* eGFR \<60 mL/min/1.73 m2, but \>15 mL/min/1.73 m2 (MDRD formula).
Exclusion Criteria:
* acute renal insufficiency;
* emergency catheterization (e.g., STEMI patients) preventing the possibility of pretreatments;
* a history of adverse reactions to contrast media;
* use of potentially nephrotoxic drugs (non-steroidal anti-inflammatory drugs, aminoglycosides, sulphonamides, cyclosporin, tacrolimus, methotrexate or platinum complexes) from 48 hours before to 24 hours after the procedure, but allowing drugs deemed essential for cardiovascular therapy (diuretics, acetylsalicylic acid, angiotensinconverting enzyme inhibitors, angiotensin receptor blockers or aliskiren);
* pulmonary edema;
* multiple myeloma and other monoclonal gammopathies;
* factors predisposing to kidney injury: diarrhea, vomiting, dehydration or bleeding;
* exposure to contrast media within 7 days before the procedure; pregnancy; -
* hypersensitivity to the active substance or to any of the excipients;
* Metabolic or respiratory alkalosis, particularly if hypochloremic (vomiting, gastrointestinal losses, diuretic therapy);
* Hypocalcemia;
* use of N-acetyl cysteine, theophylline, dopamine, fenoldopam, mannitol, citrate or bicarbonate within 48 hours before coronary angiography;
* Chronic and / or acute therapy with corticosteroid, quinidine, ephedrine and pseudoephedrine;
* urinary tract infections.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02980003
Study Brief:
Protocol Section:
NCT02980003