このページは自動翻訳されたものであり、翻訳の正確性は保証されていません。を参照してください。 英語版 ソーステキスト用。

LPS and Platelet Activation in Myocardial Infarction

2018年11月20日 更新者:Francesco Violi、University of Roma La Sapienza

Endotoxemia in Coronary Thrombus of Patients With Acute Coronary Syndrome

Platelets play a key role in the athero-thrombotic process. However, the in vivo mechanism accounting for thrombus growth at site of coronary atherosclerotic lesion has not been fully elucidated. While platelet adhesion and aggregation on the thrombogenic core of atherosclerotic plaque is an established mechanism for thrombus growth, the role of systemic factors, which may contribute to thrombus via amplification and propagation of platelet aggregation, is still to be clarified.

There is a growing body of evidence that lipopolysaccharides (LPS), are implicated in athero-thrombosis. Circulating levels of endotoxins have been associated with human atherosclerosis progression, particularly in smokers or in patients with infections. Furthermore, endotoxins seem to be implicated in the thrombotic process through several mechanisms including up-regulation of macrophage tissue factor expression and amplification of platelet response upon interaction with Toll-like receptor 4. The relationship between endotoxins and platelets may be relevant in the context of acute coronary syndromes as endotoxins could locally amplify platelet-derived thrombus growth but this issue is still unexplored.

Previous studies demonstrated that low-grade endotoxemia is detectable in human circulation, likely as consequence of enhanced gut permeability, and may be responsible for leucocyte-platelet aggregate and eventually thrombosis. The investigators hypothesize that low-grade endotoxemia may be observed in patients with coronary heart disease and may favor, at site of coronary unstable plaque, thrombus growth. To explore this issue, Escherichia Coli (EC)-LPS concentration and biomarkers of platelet activation will be measured in coronary thrombus and intra-coronary blood of patients with STEMI and stable angina (SA), respectively, and in peripheral circulation of both patients and controls. EC DNA will be searched in serum of all patients by polymerase chain reaction (PCR). Furthermore, to substantiate that LPS could be biologically active, immune-histochemical analysis of thrombi and in vitro studies will be performed to assess the interplay between LPS and platelet activation.

調査の概要

状態

完了

詳細な説明

In this case-control study, three groups of patients will be compared: consecutive STEMI patients undergoing to manual thrombo-aspiration during primary percutaneous coronary intervention, patients with chronic stable angina (SA) undergoing elective diagnostic and/or interventional coronary procedure and outpatients without coronary heart disease referring to the ambulatory of the Department of Internal Medicine, I Clinica Medica, Sapienza -University of Rome.

Patients will be recruited from three Centers: i) Department of the Heart and Great Vessels "Attilio Reale", Sapienza -University of Rome; ii) Department of Internal Medicine, I Clinica Medica, Sapienza -University of Rome; iii) Department of Interventional Cardiology, Santa Maria University Hospital, Terni.

The study complied with the Declaration of Helsinki and was approved by the local ethic committees of centers involved.

In patients presenting STEMI, coronary thrombi, when present, or plaque fragments will be aspirated from the culprit coronary artery before stent implantation and collected in EDTA tubes.

Thrombi will be homogenized in 5 mL of a homogenization buffer. Aliquots of thrombi homogenate will be centrifuged. In a subset of STEMI patients, part of the thrombotic material aspirated will be fixed in 4% buffered formaldehyde for histologic and immunohistochemical analyses.

In patients with SA, intracoronary blood will be aspirated from the stented coronary artery, before stenting, and immediately collected in EDTA tubes and centrifuged. Next, supernatant will be removed and stored at -80°C until use.

Peripheral blood samples will be obtained from a radial or femoral artery, before the start of procedure and after stent deployment in STEMI patients, or before balloon dilation and stenting in SA patients and then collected into tubes with or without 3.8% sodium citrate and EDTA tubes and centrifuged to obtain supernatant. Blood samples of controls group will be obtained from patients after supine rest for at least 10 min and taken into tubes with or without 3.8% sodium citrate and in EDTA tubes and centrifuged to obtain supernatant. Plasma and serum aliquots will be stored at -80°C in appropriate cuvettes until assayed.

Complete haemochrome, blood glucose, lipid profile, fibrinogen, creatinine, creatine kinase-MB and troponin T will be evaluated using standard methods.

sCD40L and sP-selectin levels will be measured with a commercial immunoassay in aliquots of plasma, thrombus homogenate and intracoronary blood.

Lipopolysaccharide (LPS) levels in serum and thrombus will be measured using a commercial ELISA kit.

A PCR reaction for specific amplification of a region of the 16S ribosomal RNA gene of Escherichia coli will be developed.

Serum zonulin levels will be measured using a commercial ELISA kit.

Immunoistochemistry (IHC) will be performed on sections obtained from formalin-fixed and paraffin embedded thrombus fragments aspirated from a subset of STEMI patients. After rehydration and antigen retrieval slides will be incubated with primary antibodies respectively to LPS, TLR4 and Cathepsin G, then washed in phosphate saline buffer and incubated with a secondary universal antibody. Immunoreactions will be detected with diaminobenzidine.

.

研究の種類

観察的

入学 (実際)

150

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

      • Rome、イタリア、00162
        • Internal and Medical Specialities Department - Policlinico Umberto I

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年~95年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

  1. STEMI patients referred to the catheterization laboratory for PPCI, who will undergo to manual coronary thrombo-aspiration, that fulfilled the inclusion/exclusion criteria, with a sufficient thrombotic material (≥1 mm3).
  2. patients with chronic stable angina (SA) undergoing elective diagnostic and/or interventional coronary procedure, undergoing to intracoronary blood aspiration
  3. outpatients without coronary heart disease matched for age, gender and comorbidities like diabetes and hypertension

説明

Inclusion Criteria:

For STEMI patients:

  • diagnosis of STEMI based on the current European Guidelines

For SA patients:

  • diagnosis of SA defined according to the European Guidelines as lack of episodes of coronary instability for at least 6 months prior to admission

For control subjects:

  • outpatients without diagnosis of coronary heart disease

Exclusion Criteria:

  • estimated glomerular filtration rate less than 30 ml/min/m2
  • acute or recent systemic infections (3 weeks)
  • treatment with systemic corticosteroids
  • treatment with oral anticoagulants
  • malignancy
  • lack of consent to participate

Additional exclusion criteria for STEMI patients were symptoms duration>12 h, rescue PCI, in-stent thrombosis and anatomical difficulty in reaching the lesion.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
STEMI
50 STEMI patients treated with standard therapy undergoing to primary percutaneous coronary internention (PPCI). Thromboaspiration will be performed whenever possible (when the anatomy of the coronary artery - curve and size- allowed it) in all patients with a TIMI Flow 0 and in all patients with a visible thrombus if TIMI Flow was 1 or more.
Stable angina
50 stable angina (SA) patients on standard therapy, undergoing to intracoronary blood aspiration during elective diagnostic and/or interventional coronary procedure, matched for age, sex and comorbidities with the 50 STEMI patients.
Controls
50 outpatients without coronary heart disease, matched for age gender and comorbidities like diabetes and hypertension with the 50 STEMI patients. Peripheral blood samples will be collected during routine patient monitoring.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
LPS in blood of STEMI, SA patients and controls.
時間枠:1 year
LPS will be measured in serum and expressed as concentration (pg/ml)
1 year

二次結果の測定

結果測定
メジャーの説明
時間枠
LPS in thrombus and intra-coronary blood of STEMI and SA patients.
時間枠:1 year
LPS will be measured in coronary thrombi of STEMI patients and in intra-coronary blood of SA patients and expressed as concentration (pg/ml)
1 year
sP-selectin in thrombus and intra-coronary blood of STEMI and SA patients.
時間枠:1 year
sP-selectin (a marker of platelet activation) will be measured in coronary thrombi of STEMI patients and in intra-coronary blood of SA patients and expressed as concentration (ng/ml).
1 year
sCD40L in thrombus and intra-coronary blood of STEMI and SA patients.
時間枠:1 year
sCD40L (a marker of platelet activation) will be measured in coronary thrombi of STEMI patients and in intra-coronary blood of SA patients and expressed as concentration (ng/ml).
1 year
Escherichia coli-DNA
時間枠:1 year
Escherichia coli-DNA will be searched in serum patients and controls by polymerase chain reaction (PCR).The investigators will evaluate the rate of positivity in the serum of the study population.
1 year
Histologic and immunohistochemical analyses of thrombus fragments aspirated from a subset of STEMI patients.
時間枠:1 year
Immunoistochemistry on sections obtained from formalin-fixed and paraffin embedded thrombus fragments.The investigators will analyze the composition of thrombus fragments and the presence of LPS , TLR4 and Cathepsin G.
1 year
HS-CRP in blood of STEMI, SA patients and controls
時間枠:1 year
High sensitivity-C reactive protein will be measuer in serum and expressed as concentration (mg/L).
1 year
sP-selectin in blood of STEMI, SA patients and controls.
時間枠:1 year
sP-selectin (a marker of platelet activation) will be measured in plasma and expressed as concentration (ng/ml)
1 year
Soluble CD40L (sCD40L) in blood of STEMI, SA patients and controls.
時間枠:1 year
sCD40L (a marker of platelet activation) will be measured in plasma and expressed as concentration (ng/ml)
1 year
Zonulin in blood of STEMI, SA patients and controls
時間枠:1 year
Zonulin (a marker of gut permeability) will be measued in serum and expressed as concentration (ng/ml)
1 year

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

協力者

捜査官

  • スタディチェア:Francesco Violi, MD、University of Roma La Sapienza

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2013年1月2日

一次修了 (実際)

2018年7月6日

研究の完了 (実際)

2018年11月5日

試験登録日

最初に提出

2018年9月15日

QC基準を満たした最初の提出物

2018年9月17日

最初の投稿 (実際)

2018年9月18日

学習記録の更新

投稿された最後の更新 (実際)

2018年11月21日

QC基準を満たした最後の更新が送信されました

2018年11月20日

最終確認日

2018年11月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

未定

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

3
購読する