Myocardial Infarction Clinical Trial
Official title:
Endotoxemia in Coronary Thrombus of Patients With Acute Coronary Syndrome
Verified date | November 2018 |
Source | University of Roma La Sapienza |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 150 |
Est. completion date | November 5, 2018 |
Est. primary completion date | July 6, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 95 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Italy | Internal and Medical Specialities Department - Policlinico Umberto I | Rome |
Lead Sponsor | Collaborator |
---|---|
University of Roma La Sapienza | Neuromed IRCCS |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | LPS in blood of STEMI, SA patients and controls. | LPS will be measured in serum and expressed as concentration (pg/ml) | 1 year | |
Secondary | LPS in thrombus and intra-coronary blood of STEMI and SA patients. | 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 | |
Secondary | sP-selectin in thrombus and intra-coronary blood of STEMI and SA patients. | 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 | |
Secondary | sCD40L in thrombus and intra-coronary blood of STEMI and SA patients. | 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 | |
Secondary | Escherichia coli-DNA | 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 | |
Secondary | Histologic and immunohistochemical analyses of thrombus fragments aspirated from a subset of STEMI patients. | 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 | |
Secondary | HS-CRP in blood of STEMI, SA patients and controls | High sensitivity-C reactive protein will be measuer in serum and expressed as concentration (mg/L). | 1 year | |
Secondary | sP-selectin in blood of STEMI, SA patients and controls. | sP-selectin (a marker of platelet activation) will be measured in plasma and expressed as concentration (ng/ml) | 1 year | |
Secondary | Soluble CD40L (sCD40L) in blood of STEMI, SA patients and controls. | sCD40L (a marker of platelet activation) will be measured in plasma and expressed as concentration (ng/ml) | 1 year | |
Secondary | Zonulin in blood of STEMI, SA patients and controls | Zonulin (a marker of gut permeability) will be measued in serum and expressed as concentration (ng/ml) | 1 year |
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