Clinical trial NCT03832153: Pan-Cardio-Genetics Clot Assessment in Acute Coronary Syndromes
Official title: Pan-Cardio-Genetics Clot Assessment in Acute Coronary Syndromes
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: STEMI - ST Elevation Myocardial Infarction
Thrombi
MicroRNA
Keywords: Bioprinting
thrombus aspiration
micro-CT
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: HELLENIC CENTER FOR MARINE RESEARCH
name: Harvard Medical School (HMS and HSDM)
name: Centre for Research and Technology Hellas
First posted: 2019-02-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 210 consecutive patients presenting with STEMI and undergoing thrombus aspiration will be enrolled in the study

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Patients with symptoms of myocardial ischemia lasting for more than 30 minutes
* Definite ECG changes indicating STEMI
* Patients undergoing primary PCI within 12 hours from symptom onset
* Possibility to perform thrombus aspiration
* Written informed consent

Exclusion Criteria:

* Treatment with fibrinolytic therapy for qualifying index STEMI event
* Patients with known intolerance to aspirin, ticagrelor or heparin
* Patients with active internal bleeding
* Patients with a recent history of intracranial hemorrhage

Primary outcomes:
measure: Fold changes of differentially-expressed microRNA from peripheral blood from patients suffering from STEMI (measured in log2 scale)
timeFrame: 12 months
measure: Volume of aspirated thrombus burden
timeFrame: 12 months
Secondary outcomes:
measure: Association between fold changes of microRNA expression and post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow
timeFrame: 12 months
measure: Association between fold changes of microRNA expression (measured in log2 scale) with distal embolization
timeFrame: 12 months
measure: Association between fold changes of microRNAs expression and volume of aspirated thrombus.
timeFrame: 12 months
measure: Association between fold changes of microRNA expression and Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
timeFrame: 12 months
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: AHEPA University Hospital
Study officials:
affiliation: Associate Professor of Cardiology, Aristotle University of Thessaloniki
name: Georgios Sianos
role: STUDY_CHAIR
affiliation: Associate Professor, School of Pharmacy, Aristotle University of Thessaloniki
name: Ioannis Vizirianakis
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor in Pharmaceutical Technology , Aristotle University of Thessaloniki
name: Dimitrios Fatouros
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor in Statistics, Aristotle University of Thessaloniki
name: Eleftherios Angelis
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Research, Hellenic Center for Marine Research
name: Christos Arvanitidis
role: PRINCIPAL_INVESTIGATOR
affiliation: Associate Professor, Department of Pathology, Harvard Medical School
name: James Michaelson
role: PRINCIPAL_INVESTIGATOR
affiliation: Post-Doctoral Fellow, Hellenic Center for Marine Research
name: Athanasios Zacharopoulos
role: PRINCIPAL_INVESTIGATOR
affiliation: Director of Research, Centre for Research and Technology Hellas
name: Christos Ouzounis
role: PRINCIPAL_INVESTIGATOR
affiliation: Phd Candidate, Aristotle University of Thessaloniki
name: Efstratios Karagiannidis
role: PRINCIPAL_INVESTIGATOR
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