Effectiveness of Thrombus Aspiration in Plaque Reduction for Patients With Acute Coronary Syndromes

NCT01342848 | Completed DMC

• 1 other identifier: 2010-021835-15
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 3

Brief Summary

Although successful, percutaneous coronary interventions (PCI) with stent implantation may be hampered by periprocedural myocardial necrosis. In acute ST-elevation myocardial infarction (STEMI), the reduction of thrombus burden through manual thrombus aspiration (TA) of an occluded coronary artery has been documented to produce an improved myocardial perfusion rate and significant survival advantage. To date, beyond feasibility and safety studies no clinical benefit has been yet documented with the use of TA before stent deployment in the setting of acute coronary syndromes (ACS) outside acute STEMI. The investigators hypothesize that TA before stent deployment reduces the thrombus/plaque burden - as assessed by intravascular imaging systems - in the setting of acute coronary syndromes (ACS) outside acute STEMI.

Conditions

Acute Coronary Syndrome

Keywords

NSTE-ACS; PCI; Thrombus Aspiration; IVUS; Periprocedural Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• The change in plaque volume as assessed by intravascular ultrasound (IVUS).

  The reduction of plaque volume after TA, assessed as (Baseline P+M)- (Post-TA P+M);

  From baseline to 10 minutes after thromboaspiration (TA)

Secondary Outcomes (3)

• Histopathology assessment of aspirated material.

  One week after PCI

• Myocardial infarct size by markers of myocardial injury/necrosis

  Up to 72 hours after PCI

• The change in thrombus burden as assessed by Optical Coherence Tomography (OCT)

  From baseline to 10 minutes after thromboaspiration (TA)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

45 patients with at least one "culprit" lesion, identified as a high-grade (\>90%) lesion in the territory of jeopardized myocardium, at coronary angiography performed for a recent (\<15 days, but after 24 hours) STEMI or a non-ST elevation (NSTE)-ACS within 72 hours of symptoms.

You may qualify if:

• Age between 18-75 years old.
• Recent(\<15 days, \>24 hrs)STEMI or NSTE-ACS within 72 hrs of symptoms.
• Presence at least one "culprit" high-grade (\>90%)lesion.

You may not qualify if:

• STEMI within 24 hours.
• Cardiogenic shock, decompensated heart failure, LVEF\<30%.
• Serum creatinine ≥ 2.5 mg/dl.
• Contraindication to aspirin, heparin, thienopyridines.
• Total occlusion of target vessel.
• Diseased vein graft or a restenosis.

Sponsors & Collaborators

• Raffaele De Caterina: lead
• San Giovanni Addolorata Hospital: collaborator

Study Sites (3)

Center of Predictive Molecular Medicine - University "G. d'Annunzio"

Chieti, 66013, Italy

Location

Institute of Cardiology, G. d'Annunzio University

Chieti, 66100, Italy

Location

San Giovanni Hospital and Centro per la Lotta Contro l'Infarto, Fondazione Onlus

Rome, 00184, Italy

Location

Related Publications (14)

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Biospecimen

Retention: SAMPLES WITHOUT DNA

Histopathology assessment of aspirated material during manual TA. Quantitative analysis: size and weight. Qualitative evaluation: a) thrombus containing only platelets, b) a thrombus with an erythrocyte component c) any fragment of vessel wall, cholesterol crystals, inflammatory cells or collagen tissue

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director - Institute of Cardiology

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: April 27, 2011
• Study Start: March 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 8, 2015

Record last verified: 2015-06

Locations

IT (3)