Clinical Trial: THE LASER-AMI STUDY - Excimer Laser Versus Manual Thrombus Aspiration in Acute Myocardial Infarction
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
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
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 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.
Detailed Summary:
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 in order to restore normal blood flow to the myocardium, thus preventing left ventricular (LV) adverse remodelling and occurrence of heart failure. Primary percutaneous coronary intervention (PPCI) represents the pivotal step in the current management of ST-segment elevation myocardial infarction (STEMI) (1). Yet, in a sizable proportion of patients, PPCI achieves epicardial coronary artery reperfusion but not myocardial reperfusion, a condition known as no-reflow (2), that increases the extent of myocardial damage. The proportion of patients who get optimal myocardial reperfusion, among those without cardiogenic shock undergoing PPCI, is about 35% (3). Thus, the prevalence of no-reflow remains extremely high. Furthermore, a series of consistent data has clearly shown that no-reflow has a strong negative impact on outcome, negating the potential benefit of PPCI (4-10). Indeed, as compared to patients without no-reflow, patients with no-reflow exhibit a higher prevalence of: 1) early post-infarction complications (arrhythmias, pericardial effusion, cardiac tamponade, early congestive heart failure); 2) LV adverse remodelling; 3) late re-hospitalizations for heart failure; 4) mortality. In man, no-reflow is caused by the variable combination of four pathogenetic mechanisms: 1) distal atherothrombotic embolization, 2) ischemic injury, 3) reperfusion injury, 4) susceptibility of coronary microcirculation to injury (3). As a consequence, appropriately designed strategies to prevent or to treat, at the right time, each of these components are expected to reduce the final number of patients with no-reflow. Manual thrombus aspiration (MTA) has been clearly shown to improve microvascular perfusion and survival in STEMI patients treat
Sponsor: Catholic University of the Sacred Heart
Current Primary Outcome: Rate of major adverse cardiac events [ Time Frame: 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Catholic University of the Sacred Heart
Dates:
Date Received: March 28, 2013
Date Started: April 2014
Date Completion:
Last Updated: November 11, 2014
Last Verified: November 2014
