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 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 12:27 AM
NCT ID:
NCT03400267
Eligibility Criteria:
Inclusion Criteria:
i. age ≥18 years
ii. referred by ambulance paramedics to Isala (Zwolle) or Zuyderland Hospital (Heerlen)
iii. diagnosed in the ambulance with STEMI defined as:
1. ongoing chest pain \>30 minutes and \<12 hours duration and
2. ST-segment elevation \>0.1 milliVolt in at least 2 contiguous leads
iv. ongoing chest pain with a pain score (NRS) ≥4
v. the patient has been informed of the nature of the study, agrees to its provisions and has provided verbal informed consent in the pre-hospital phase followed by written informed consent in hospital
Exclusion Criteria:
i. presenting with cardiogenic shock; defined as:
1. systolic blood pressure \<90 mmHg and
2. heart rate \>100/min and
3. peripheral oxygen saturation \<90% (without oxygen administration)
ii. patients with a nasogastric tube in situ or requiring a nasogastric tube
iii. patients who already received fentanyl or paracetamol \<2 hours prior to randomization
iv. patients on current treatment with P2Y12 inhibitors (ticagrelor, clopidogrel or prasugrel)
v. allergy to morphine or paracetamol
vi. patients with recent major bleeding complications or contraindication to dual antiplatelet therapy:
1. hypersensitivity to aspirin or ticagrelor
2. current use of (new) oral anticoagulation
3. history of bleeding diathesis or known coagulopathy
4. active bleeding
5. refusal of blood transfusions
6. history of intracerebral mass, aneurysm, arteriovenous malformation, or hemorrhagic stroke
7. known severe liver dysfunction
vii. received any organ transplant or is on a waiting list for any organ transplant
viii. patients undergoing dialysis
ix. pregnant or lactating female
x. patients currently participating in another investigational drug or device study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03400267
Study Brief:
Protocol Section:
NCT03400267