THE LASER-AMI STUDY - Excimer Laser Versus Manual Thrombus Aspiration in Acute Myocardial Infarction

NCT01826006 | Unknown DMC

• 1 other identifier: LASER-AMI P/915/CE/2012
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; No-reflow; Primary PCI; Coronary no-reflow phenomenon; Primary percoutaneous coronary intervention (primary PCI)

Outcome Measures

Primary Outcomes (1)

• Rate of major adverse cardiac events

  6 months

Study Arms (2)

Excimer laser

ACTIVE COMPARATOR

After wire crossing, Excimer Laser will be performed. Consequently, intracoronary adenosine will be selectively administered through the guiding catheter.

Device: Excimer laser

Manual Thrombus Aspiration

ACTIVE COMPARATOR

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

Interventions

Excimer laser DEVICE

Excimer laser

Manual Thrombus Aspiration DEVICE

Manual Thrombus Aspiration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Dipartimento Medicina Cardiovascolare

Rome, 00168, Italy

RECRUITING

Related Publications (40)

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MeSH Terms

Conditions

Myocardial Infarction

Interventions

Lasers, Excimer

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Giampaolo Niccoli, MD, PhD

CONTACT

0630151; gniccoli73@hotmail.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dott. Prof.

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 8, 2013
• Study Start: April 1, 2014
• Primary Completion: April 1, 2015
• Last Updated: November 13, 2014

Record last verified: 2014-11

Locations

IT (1)