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 @ 12:21 PM
Ignite Modification Date:
2025-12-24 @ 12:21 PM
NCT ID:
NCT01007461
Eligibility Criteria:
Inclusion Criteria:
1. Presentation to study hospital or institution with diagnosis of STEMI based on clinical and ECG findings (subject presented with ≥ 30 minutes of ischemic chest pain, within 12 hours of symptom onset, and has persistent ST-segment elevation of ≥ 2 mm ST-segment elevation in at least 2 contiguous leads in the ECG.
2. Age between 18 and 80 years (inclusive)
3. Signed Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved informed consent form
Exclusion Criteria:
1. Prior MI (as determined by subject history and/or ECG), cardiac surgery, or severe pericardial, congenital, cardiomyopathic, or valvular heart disease
2. Cardiac arrest within the past 28 days
3. Requirement for urgent cardiac surgery
4. Previous CABG surgery or PCI
5. Evidence of moderate or severe CHF (Killip Classes III and IV)
6. Any bradyarrhythmia that is expected to require a pacemaker through Day 4 (range 3 to 5 days), thus preventing the MRI
7. Unable to undergo a MRI (including disallowed metallic implants, unable to tolerate gadolinium contrast media, morbid obesity, or severe claustrophobia)
8. Subjects with past or current renal impairment requiring dialysis
9. Active or recent hemorrhage requiring an invasive procedure for evaluation or transfusion or hemorrhagic stroke within 6 weeks prior to presentation
10. Known or suspected aortic dissection
11. Subjects who have received treatment for asthma within the past 12 months
12. Prior history of pulmonary disease requiring chronic oxygen therapy
13. Females of childbearing potential
14. Body weight \> 150 kg or Body Mass Index (BMI) \> 40 kg/m2
15. Medical problem likely to preclude completion of the study
16. Use of investigational drugs or devices within 30 days prior to enrollment into the study
17. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
18. Known food allergy to sulfite-containing foods and/or any drug allergies to drugs that contain sulfur
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT01007461
Study Brief:
Protocol Section:
NCT01007461