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 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 1:32 AM
NCT ID:
NCT02604394
Eligibility Criteria:
Inclusion Criteria:
* STEMI with time from symptom onset of \<12 hours duration.
* STEMI with time from symptom onset \< 24 hours, in the presence of ongoing ischaemia, life-threatening arrhythmias or if pain and ECG changes have been stuttering.
Exclusion Criteria:
* Clinical exclusion criteria:
1. STEMI patients receiving fibrinolytic therapy.
2. Cardiogenic shock.
3. Patients with clinical, hemodynamic, or electrical instability as well as those judged to be critically ill or when there is need to minimize the procedure length to the shortest possible time.
4. Patients refusing to participate in the study.
* Angiographic exclusion criteria:
1. Infarct artery reference vessel diameter \<2.5 mm on visual assessment.
2. Previously stented infarct artery.
3. TIMI thrombus grade \< 4.
4. Inability to identify the infarct artery.
* Contraindications to adenosine:
1. Second or third degree atrioventricular block
2. Sick sinus syndrome
3. Systolic blood pressure less than 90 mm Hg
4. Sinus bradycardia (heart rate\<40 bpm)
5. Active bronchospastic disease with regular use of inhalers
6. Known hypersensitivity to adenosine
* Contraindications to CMR :
1. Cerebral aneurysm clips
2. MRI non compatible cardiac pacemaker
3. Implanted cardioverter-defibrillator
4. Retained transvenous pacemaker and defibrillator leads
5. Electronic implant or device, eg, insulin pump or other infusion pump
6. Cochlear, otologic, or other ear implant
7. Shunt (spinal or intraventricular)
8. Tissue expander (eg, breast)
9. Joint replacement (eg, hip, knee, etc)
10. Any type of prosthesis (eg, eye, penile, etc)
11. Known claustrophobia
12. Body piercing jewelry
13. Known/possible pregnancy or breast feeding.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT02604394
Study Brief:
Protocol Section:
NCT02604394