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 @ 2:44 AM
Ignite Modification Date:
2025-12-25 @ 2:44 AM
NCT ID:
NCT01281033
Eligibility Criteria:
Inclusion Criteria:
Clinical inclusion criteria:
* Patient is \> 18 years of age.
* Patient has ST-segment elevation of at least 0.1 mV in 2 or more contiguous leads or presumably new LBBB for all types of infarcts.
* Patient's AMI presentation is greater than 30 minutes but less than 6 hours after symptom onset.
* Patient provides written informed consent. Patient has no childbearing potential or is not pregnant
Angiographic inclusion criteria:
* All patients with or without evidence of thrombus are eligible.
* Target artery has a reference vessel diameter 2.5 mm on visual assessment at baseline angiography.
Exclusion Criteria:
Clinical exclusion criteria:
* Known prior history of renal insufficiency (serum creatinine 2.0 mg/dL).
* Cardiogenic shock.
* Prior administration of thrombolysis for the current infarction.
* Participation in another study.
* Major surgery within past 6 weeks.
* History of stroke within 30 days, or any history of hemorrhagic stroke.
* Severe hypertension (systolic BP \> 200 mm Hg or diastolic BP \> 110 mm Hg) not controlled on antihypertensive therapy.
* Known neutropenia ( \<1000 neutrophils per mm3) or known severe thrombocytopenia (\< 50,000 platelets per mm3).
* Patient unwilling to receive blood products
Angiographic exclusion criteria:
* Previously stented IRA (stent thrombosis).
* Inability to identify the IRA.
* Severe vessel tortuosity that enables OCT assessment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01281033
Study Brief:
Protocol Section:
NCT01281033