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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
Sponsor:
Information provided by (Responsible Party):
GIANPAOLO NICCOLI, Catholic University of the Sacred Heart

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.


Condition or disease Intervention/treatment Phase
Myocardial Infarction Device: Excimer laser Device: Manual Thrombus Aspiration Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Rate of major adverse cardiac events [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Contacts
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Contact: Giampaolo Niccoli, MD, PhD 0630151 ext 4187 gniccoli73@hotmail.it

Locations
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Italy
Dipartimento Medicina Cardiovascolare Recruiting
Rome, Italy, 00168
Contact: Giampaolo Niccoli, MD, PhD    0630151 ext 4187    gniccoli73@hotmail.it   
Principal Investigator: Giampaolo Niccoli, MD, PhD         
Sponsors and Collaborators
Catholic University of the Sacred Heart

Publications:
Grundfest WS, Segalowitz J, Laudenslager JB, et al. The physical and biological basis for laser angioplasty. In: Litvack F, editor. Coronary laser angioplasty. Oxford: Blackwell Scientific Publications, 1992:5-12
Ferrante G, Cosentino N, Conte M, et al. Rescue excimer laser coronary angioplasty after manual thrombus aspiration failure in acute ST-elevation myocardial infarction. Il Giornale Italiano di Cardiologia Invasiva 2009,2:9-12
Dave RM. Excimer laser in acute myocardial infarction: first report of the Extended FAMILI Study. TCT, 2006

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Responsible Party: GIANPAOLO NICCOLI, Dott. Prof., Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT01826006     History of Changes
Other Study ID Numbers: LASER-AMI P/915/CE/2012
LASER-AMI P/915/CE/2012
First Posted: April 8, 2013    Key Record Dates
Last Update Posted: November 13, 2014
Last Verified: November 2014
Keywords provided by GIANPAOLO NICCOLI, Catholic University of the Sacred Heart:
Myocardial Infarction
No-reflow
Primary PCI
Coronary no-reflow phenomenon
Primary percoutaneous coronary intervention (primary PCI)
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases