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 @ 10:10 PM
Ignite Modification Date:
2025-12-24 @ 10:10 PM
NCT ID:
NCT05435235
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years or more.
2. Scheduled/non-emergent Percutaneous coronary intervention (PCI).
3. Post-index procedure Staged PCI with at least 14 days from contrast exposure.
4. Patient can fully understand the study information and sign informed consent.
Exclusion Criteria:
1. Cardiogenic shock /need for inotrope or mechanical pump support.
2. Acute kidney injury as defined by KDIGO criteria (\<4 weeks) prior to PCI.
3. End-Stage Renal Disease prior to PCI (On renal replacement therapy).
4. Diabetes Mellitus type 1.
5. Active diabetic ketoacidosis or uncontrolled hyperglycemia (blood glucose \>400 mg/dl).
6. ST-segment elevation Myocardial Infarction undergoing index PCI.
7. Active Genitourinary infection.
8. Diagnostic Left Heart Catheterization without PCI.
9. Patients undergoing zero contrast PCI.
10. Participation in a randomized controlled pharmaceutical or treatment-related cardiac or pulmonary clinical study within 1 month prior to randomization.
11. Coexistent hemodynamically significant valvulopathy (Symptomatic and/or severe).
12. Patients with Acute Heart Failure admission \< 30 days prior to PCI.
13. Intercurrent illness resulting in volume depletion and hypotension (MAP\<60 mmHg).
14. Patients with a kidney transplant.
15. Any contrast exposure within 14 days.
16. Patients with estimated glomerular filtration rate (eGFR) \< 25 cc/min (Recommended eGFR threshold by Food and Drug Administration labeling).
17. Patients with an active intrinsic inflammatory or autoimmune renal pathology.
18. Women of child bearing age (\<50 years old).
19. Prison Inmates
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05435235
Study Brief:
Protocol Section:
NCT05435235