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:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 12:33 AM
NCT ID:
NCT02516267
Eligibility Criteria:
Inclusion Criteria:
1. Age\> 18 years;
2. Hospitalization for ACS defined as:
\- Symptoms ischemic unstable pattern, occurring at rest or upon exertion within 72 hours of an unscheduled hospitalization, related to presumed or proven coronary artery, and at least one of the following:
* elevated cardiac biomarkers (troponin I or CK-MB mass) above the 99th percentile.
* Changes in resting electrocardiogram compatible with ischemia or infarction and further evidence of obstructive coronary artery disease:
the resting ECG compatible with ischemia or infarction in at least one of the criteria below:
* ST segment depression of new or presumably new\> 0.5 mm in 2 sequential leads.
* The new ST-segment elevation or presumed new J point in two contÃnguas leads with value\> 0.2mV in men or\> 0.15mV in women in V2-V3 and / or\> 0.1mV in other leads or new left bundle branch block or presumably again.
* T wave inversion new or presumably new\> 1mm in leads with a broad R wave in two contiguous leads.
* New pathological Q wave or presumably new\> 30 ms duration and\> 1mm deep in 2 contiguous leads or\> 20 ms or QS complex in V2 and V3.
* Peaked new R Wave\> 40 ms in V1 and V2, R / S\> 1 in V1 with positive T wave in the absence of consistent driving change.
* Additional evidence of coronary artery disease in at least one of the criteria below:
* Evidence of myocardial ischemia or new or presumably new in imaging with perfusion.
* Contractility Change in new or presumably new wall.
* Coronary angiography with obstruction\> 70% in epicardial coronary artery.
3. Use of dual antiplatelet therapy (ASA associated with P2Y12 receptor inhibitor);
4. An indication of CABG.
5. Agreement to sign the Informed Consent (IC);
Exclusion criteria:
1. anemia (hematocrit \<30%).
2. Thrombocytopenia (\<100,000 / mm³).
3. Coagulopathy (history of bleeding diathesis or use of oral anticoagulants).
4. Chronic renal failure dialysis or creatinine clearance \<30 ml / min / m2 (estimated by MDRD formula).
5. Active liver disease.
6. combined valvuloplasty or valve replacement surgery ..
7. Angioplasty with stent for less than 30 days or with drug-eluting stents for less than one year.
8. Use of fibrinolytic specific fibrin not less than 48 hours or specific fibrin less than 24 hours of randomization;
9. Any medical condition that in the investigator's opinion present significant risk to the patient or interfere with the interpretation of the safety and efficacy;
10. Patients who are taking part in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02516267
Study Brief:
Protocol Section:
NCT02516267