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:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2025-12-26 @ 1:18 PM
NCT ID:
NCT01826006
Eligibility Criteria:
Inclusion Criteria:
* Onset of symptoms of MI less than 12 hours prior to enrolment;
* ST-segment elevation of at least 2 mm in two or more contiguous leads;
* Vessel and lesion amenable to both coronary laser and manual trhombus aspiration (lack of marked vessel/lesion tortuosity or calcification; reference vessel diameter \>2.5 mm in diameter);
* Written informed consent.
Exclusion Criteria:
* Rescue angioplasty after failed thrombolysis;
* Stent thrombosis;
* Culprit lesion located in a bypass graft or in the left main trunk;
* Cardiogenic shock;
* Young age (\< 18 years);
* Severe renal failure (creatinine clearance ≤30 ml/min);
* Concomitant disease resulting in a life expectancy of less than 6 months;
* Pregnancy;
* Contraindications to contrast agents not manageable medically, or to study medications, including aspirin, clopidogrel, ticlopidine and heparin;
* Left bundle branch block, paced rhythm, frequent ventricular ectopy, pre-excitation or other ECG abnormalities interfering with the analysis of ST-segment resolution;
* Markedly depressed LV function (LVEF \<30%); Culprit lesion cannot be identified;
* Severe left main or triple vessel disease requiring CABG during the index hospitalization;
* Patients already involved in other ongoing trials;
* Patients unable or unwilling to give their informed consent.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01826006
Study Brief:
Protocol Section:
NCT01826006