Skip to main content
OpenTrials
Completed

NCT Number: NCT01342848

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

About this study

Periprocedural myocardial infarction (MI) has an independent adverse prognostic relevance. Several trials have documented a reduction in the occurrence of periprocedural MI through various pharmacological strategies, with enhanced inhibition of platelet aggregation or high dose statins. However, real-world registries still document an incidence of periprocedural MI in 30-40% of patients. Currently available intravascular imaging techniques, Intravascular Ultrasound (IVUS) and more recently available Optical Coherence Tomography (OCT) allow a precise evaluation of the coronary plaque and can be extremely useful for monitoring plaque modifications obtained with thrombus aspiration (TA). Plaque burden will be assessed as plaque + media (P+M), commonly measured with IVUS by subtracting lumen (L) to external elastic membrane (EEM) cross sectional area (P+M= EEM-L).

Expecting a mean plaque volume of 160±50 mm3 in a population of patients with ACS undergoing PCI, a sample size of at least 45 patients (52 lesions) with a recent (<15 days, but after 24 hours) STEMI or a non-ST elevation (NSTE)-ACS within 72 hours of symptoms would provide a 90% power to detect a 20% reduction in the plaque volume after TA with an alpha (probability value) of 0.05.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

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

    Time frame: From baseline to 10 minutes after thromboaspiration (TA)

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

Secondary outcomes

  1. Histopathology assessment of aspirated material.

    Time frame: One week after PCI

    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.

  2. Myocardial infarct size by markers of myocardial injury/necrosis

    Time frame: Up to 72 hours after PCI

    Myocardial infarct size will be determined as the area under the curve of serial CK-MB and cardiac Troponin I assessment

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

    Time frame: From baseline to 10 minutes after thromboaspiration (TA)

    Thrombus burden will be assessed with a semiquantitative scale (0-4) by OCT at baseline and after TA

Sponsors and collaborators

Lead sponsor

Raffaele De Caterina

Other

Collaborators

  • San Giovanni Addolorata Hospital

Registry information

Official study title

REduction of Myocardial Necrosis Achieved With Nose-dive Manual Thrombus Aspiration

Acronym: REMNANT

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2011
Registry last updated
Jun 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.