THE LASER-AMI STUDY - Excimer Laser Versus Manual Thrombus Aspiration in Acute Myocardial Infarction (LASER-AMI)
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|ClinicalTrials.gov Identifier: NCT01826006|
Recruitment Status : Unknown
Verified November 2014 by GIANPAOLO NICCOLI, Catholic University of the Sacred Heart.
Recruitment status was: Recruiting
First Posted : April 8, 2013
Last Update Posted : November 13, 2014
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 prognosis at follow up and an unfavourable left ventricular remodelling. Two main pathogenetic mechanisms cause no-reflow: distal embolization, ischemia-reperfusion injury and individual susceptibility. In such a context, Excimer Laser (EL) may play an important role in order to reduce the rate of microvascular obstruction.
Thus, in this randomized study we will assess the effect of EL versus Manual Thrombus Aspiration for ST elevation MI using ST segment resolution on standard 12 leads ECG as primary endpoint of myocardial reperfusion.
|Condition or disease||Intervention/treatment||Phase|
|Myocardial Infarction||Device: Excimer laser Device: Manual Thrombus Aspiration||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||194 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||A Randomized Comparison of Excimer LASER vs Manual Thrombus Aspiration for the Prevention of No-reflow During Primary Percutaneous Coronary Intervention of St-elevation Myocardial Infarction(LASER-AMI Study)|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||April 2015|
Active Comparator: Excimer laser
After wire crossing, Excimer Laser will be performed. Consequently, intracoronary adenosine will be selectively administered through the guiding catheter.
Device: Excimer laser
Active Comparator: Manual Thrombus Aspiration
After wire crossing, thrombus aspiration will be performed. The device will removed outside the body, flushed with saline and subsequently reintroduced in the culprit vessel beyond the occlusion site and intracoronary adenosine will be selectively administered.
Device: Manual Thrombus Aspiration
- Rate of major adverse cardiac events [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01826006
|Contact: Giampaolo Niccoli, MD, PhD||0630151 ext firstname.lastname@example.org|
|Dipartimento Medicina Cardiovascolare||Recruiting|
|Rome, Italy, 00168|
|Contact: Giampaolo Niccoli, MD, PhD 0630151 ext 4187 email@example.com|
|Principal Investigator: Giampaolo Niccoli, MD, PhD|