Status:
UNKNOWN
THE LASER-AMI STUDY - Excimer Laser Versus Manual Thrombus Aspiration in Acute Myocardial Infarction
Lead Sponsor:
Catholic University of the Sacred Heart
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The occurrence of no-reflow phenomenon after recanalization of the infarct related artery in acute myocardial infarction is described in up to 40% of cases. This event is associated with a worse progn...
Detailed Description
Acute myocardial infarction (AMI) is the leading cause of death in developed countries. In patients with AMI, prompt reopening of an occluded coronary artery is the main goal of reperfusion therapies ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
194 Patients enrolled
Trial Details
Trial ID
NCT01826006
Start Date
April 1 2014
Last Update
November 13 2014
Active Locations (1)
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1
Dipartimento Medicina Cardiovascolare
Rome, Italy, 00168