Pan-Cardio-Genetics Clot Assessment in Acute Coronary Syndromes

NCT03832153 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2022-03-03

No results posted yet for this study

Summary

Acute myocardial infarction with ST elevation (STEMI) is one of the leading causes of mortality. Although the presence of thrombus in STEMI patients has been linked to adverse outcomes, routine thrombus aspiration has not been proven effective. A potential explanation could be that patients with STEMI should be risk-stratified. Thus, a more personalized approach in treating these patients is stressfully required. This proposal aims to establish the required interdisciplinary infrastructure for developing a risk-stratification model by implementing clinical, laboratory and angiographic data with molecular knowledge obtained by using innovative technologies, such as data from nano/micro-Computed tomography and circulating microRNAs. Two hundred consecutive patients with STEMI undergoing thrombus aspiration will be enrolled in the study and will be followed-up for one year for Major Adverse Cardiac and Cerebrovascular events (MACCE). The proposed approach will shed light on the pathophysiological mechanisms and broaden the investigator's understanding of the complex cellular and molecular interactions in the STEMI setting that, along with clinical parameters, affect patient outcomes. Furthermore, it will enable the identification of certain circulating micro-RNAs as cardiovascular disease biomarkers and it will help clinicians to better stratify the cardiovascular and cerebrovascular risk of patients with STEMI. As part of the work, important characteristics of aspirated thrombi will be assessed for the first time (such as volume, density and shape) and will be linked to patient outcomes. All this information will be incorporated into one in-vitro model, which will be developed using bioprinting and microfluidics methodologies. The in-vitro model will facilitate: (i) the in-depth exploration of the pathophysiological mechanisms in patients with STEMI; and (ii) the therapeutic optimization of innovative nanocarriers/nanomedicines with thrombolytic efficacy. Clearly, the study improves personalized cardiovascular medicine approaches, by considering individual patient clinical assessment in a way that empowers the precision in diagnosis and therapy.

Conditions

  • STEMI - ST Elevation Myocardial Infarction
  • Thrombi
  • MicroRNA

Interventions

PROCEDURE

thrombus aspiration

Thrombus aspiration will be performed by experienced interventional cardiologists according to standard practices, as previously described. The intracoronary blood samples will be collected as well during the same procedure and- along with peripheral blood samples- they will be analyzed for the presence of specific miRNAs. The aspirated thrombi will be preserved in 10% formalin solution and will be analyzed using the micro/nano-CT scanners.

Sponsors & Collaborators

  • HELLENIC CENTER FOR MARINE RESEARCH

    collaborator UNKNOWN
  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER
  • Centre for Research and Technology Hellas

    collaborator OTHER
  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Georgios Sianos · Associate Professor of Cardiology, Aristotle University of Thessaloniki

  • Ioannis Vizirianakis · Associate Professor, School of Pharmacy, Aristotle University of Thessaloniki

  • Dimitrios Fatouros · Associate Professor in Pharmaceutical Technology , Aristotle University of Thessaloniki

  • Eleftherios Angelis · Professor in Statistics, Aristotle University of Thessaloniki

  • Christos Arvanitidis · Director of Research, Hellenic Center for Marine Research

  • James Michaelson · Associate Professor, Department of Pathology, Harvard Medical School

  • Athanasios Zacharopoulos · Post-Doctoral Fellow, Hellenic Center for Marine Research

  • Christos Ouzounis · Director of Research, Centre for Research and Technology Hellas

  • Efstratios Karagiannidis · Phd Candidate, Aristotle University of Thessaloniki

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-20
Primary Completion
2022-03-30
Completion
2022-03-30

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03832153 on ClinicalTrials.gov