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 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
NCT01467466
Eligibility Criteria:
Inclusion Criteria:
* Planned elective or urgent coronary or non-coronary angiography with iodinated contrast media in which it is anticipated that there will be an interval of 3 hours between the identification of the indication for angiography and the time of the planned procedure.
* Pre-angiography eGFR \<60 ml/min/1.73 m2 with diabetes mellitus or pre-angiography eGFR \<45 ml/min/1.73 m2 with or without diabetes mellitus
* Ability to provide informed consent
Exclusion Criteria:
* Stage 5 chronic kidney disease (CKD) (eGFR \<15 mL/min/1.73 m2)
* Currently receiving hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low efficiency dialysis (SLED)
* Unstable baseline serum creatinine (SCr) (if known) at the time of angiography defined by an increase in SCr of 25% over the 3 days prior to angiography
* Decompensated heart failure requiring any of the following therapies at the time of angiography:
* IV milrinone, amrinone, dobutamine, or nesiritide
* Isolated ultrafiltration therapy
* Intra-aortic balloon pump
* Emergent angiography procedures defined as an anticipated duration of \<3 hours between the identification of the indication for angiography and the time of the planned procedure.
* Receipt of intravascular iodinated contrast within the 5 days preceding angiography
* Receipt of oral or IV NAC within the 48 hours preceding angiography
* Known allergy to N-acetylcysteine (NAC)
* Known anaphylactic allergy to iodinated contrast media
* Prisoner
* Age \<18 years
* Pregnancy
* Ongoing participation in an unapproved concurrent interventional study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01467466
Study Brief:
Protocol Section:
NCT01467466