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 @ 11:30 PM
Ignite Modification Date:
2025-12-24 @ 11:30 PM
NCT ID:
NCT04765956
Eligibility Criteria:
Inclusion Criteria:
* Patient has an acute coronary syndrome without ST-segment elevation on the ECG (NSTE-ACS), including non-ST-elevation myocardial infarction and unstable angina pectoris, defined according to the Fourth Universal Definition of Myocardial Infarction.
* An invasive revascularization strategy for NSTE-ACS with PCI is chosen.
Exclusion Criteria:
\- Angiographic exclusion criteria:
1. Previous coronary artery bypass-grafting;
2. Presence of a chronic total occlusion;
3. Too many (complex) coronary lesions requiring staged PCI procedure(s);
4. Procedural complication of the index PCI;
\- Clinical exclusion criteria:
5. Unstable patients (the presence of cardiogenic shock, need for intubation, need for inotropes);
6. Patients with ST-segment elevations on the ECG requiring immediate primary PCI;
7. Body weight \> 250 kg;
8. Known renal insufficiency (estimated Glomerular Filtration Rate \[eGFR\] \<30 mL/min/1.73m2 or subject on dialysis);
9. Hypersensitivity or allergy to contrast with inability to properly pre-hydrate;
10. Presence of a comorbid condition with a life expectancy of less than one year;
11. Participation in another trial;
12. Subject is belonging to a vulnerable population (per investigator's judgment, e.g., subordinate hospital staff) or is unable to read or write.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT04765956
Study Brief:
Protocol Section:
NCT04765956