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 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT04023266
Eligibility Criteria:
Inclusion Criteria:
Patients presenting with STEMI within 3 hours of symptom onset and satisfying all of the following criteria:
1. Patient age ≥ 18 years
2. Have received thrombolysis, with intend to pursue a pharmaco-invasive reperfusion strategy. Onset of chest pain to reperfusion time of \< 3hrs.
3. STEMI involving anterior and/or inferior wall
4. An absence of baseline Q-waves on the initial ECG: The presence of Q waves defined at baseline using the Selvester QRS screening criteria
5. Have a high-risk STEMI ECG defined as:
* ≥2mm ST-segment elevation in 2 anterior or lateral leads; or
* ≥2 mm ST-segment elevation in 2 inferior leads coupled with ST-segment depression in 2 contiguous anterior leads for a total ST-segment deviation of ≥4 mm
Exclusion Criteria:
1. Previous myocardial infarction
2. Known to have moderate to severe LV systolic dysfunction (LV EF\< 45%)
3. Known allergy to thrombolytic therapy or NAC
4. Presence of left bundle branch block
5. Cardiogenic shock (defined as systolic blood pressure of \< 90mm Hg, for at least 30 minutes, not responsive to fluid resuscitation)
6. Permanent pacemaker or cardioverter defibrillator implanted previously
7. Patients with contra-indications to thrombolytic therapy
8. Patients with loss of consciousness or confusion
9. Patients with known chronic kidney disease (GFR \< 30ml/min/m2) or on dialysis
10. Current pregnancy
11. Planned therapy with primary PCI
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04023266
Study Brief:
Protocol Section:
NCT04023266