Pan-Cardio-Genetics Clot Assessment in Acute Coronary Syndromes

NCT ID: NCT03832153

Last Updated: 2022-03-03

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-20
• Study Completion Date: 2022-03-30

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.

Conditions

STEMI - ST Elevation Myocardial Infarction; Thrombi; MicroRNA

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with low thrombus burden

patients with the lower volume of aspirated thrombi, as measured using micro-CT

thrombus aspiration

Intervention Type: PROCEDURE

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.

patients with high thrombus burden

patients with the higher volume of aspirated thrombi, as measured using micro-CT

thrombus aspiration

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HELLENIC CENTER FOR MARINE RESEARCH

UNKNOWN

Sponsor Role: collaborator

Harvard Medical School (HMS and HSDM)

OTHER

Sponsor Role: collaborator

Centre for Research and Technology Hellas

OTHER

Sponsor Role: collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Karagiannidis Efstratios

Medical Doctor (resident physician, Cardiology Department, AHEPA University hospital), PhD candidate, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Georgios Sianos

Role: STUDY_CHAIR

Associate Professor of Cardiology, Aristotle University of Thessaloniki

Ioannis Vizirianakis

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, School of Pharmacy, Aristotle University of Thessaloniki

Dimitrios Fatouros

Role: PRINCIPAL_INVESTIGATOR

Associate Professor in Pharmaceutical Technology , Aristotle University of Thessaloniki

Eleftherios Angelis

Role: PRINCIPAL_INVESTIGATOR

Professor in Statistics, Aristotle University of Thessaloniki

Christos Arvanitidis

Role: PRINCIPAL_INVESTIGATOR

Director of Research, Hellenic Center for Marine Research

James Michaelson

Role: PRINCIPAL_INVESTIGATOR

Associate Professor, Department of Pathology, Harvard Medical School

Athanasios Zacharopoulos

Role: PRINCIPAL_INVESTIGATOR

Post-Doctoral Fellow, Hellenic Center for Marine Research

Christos Ouzounis

Role: PRINCIPAL_INVESTIGATOR

Director of Research, Centre for Research and Technology Hellas

Efstratios Karagiannidis

Role: PRINCIPAL_INVESTIGATOR

Phd Candidate, Aristotle University of Thessaloniki

Locations

AHEPA University Hospital

Thessaloniki, , Greece

Countries

Greece

References

Sianos G, Papafaklis MI, Daemen J, Vaina S, van Mieghem CA, van Domburg RT, Michalis LK, Serruys PW. Angiographic stent thrombosis after routine use of drug-eluting stents in ST-segment elevation myocardial infarction: the importance of thrombus burden. J Am Coll Cardiol. 2007 Aug 14;50(7):573-83. doi: 10.1016/j.jacc.2007.04.059. Epub 2007 Jul 30.

Reference Type: BACKGROUND

PMID: 17692740 (View on PubMed)

Ibanez B, James S, Agewall S, Antunes MJ, Bucciarelli-Ducci C, Bueno H, Caforio ALP, Crea F, Goudevenos JA, Halvorsen S, Hindricks G, Kastrati A, Lenzen MJ, Prescott E, Roffi M, Valgimigli M, Varenhorst C, Vranckx P, Widimsky P; ESC Scientific Document Group. 2017 ESC Guidelines for the management of acute myocardial infarction in patients presenting with ST-segment elevation: The Task Force for the management of acute myocardial infarction in patients presenting with ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2018 Jan 7;39(2):119-177. doi: 10.1093/eurheartj/ehx393. No abstract available.

Reference Type: BACKGROUND

PMID: 28886621 (View on PubMed)

Grover SP, Saha P, Jenkins J, Mukkavilli A, Lyons OT, Patel AS, Sunassee K, Modarai B, Smith A. Quantification of experimental venous thrombus resolution by longitudinal nanogold-enhanced micro-computed tomography. Thromb Res. 2015 Dec;136(6):1285-90. doi: 10.1016/j.thromres.2015.10.006. Epub 2015 Oct 9.

Reference Type: BACKGROUND

PMID: 26489729 (View on PubMed)

Vorpahl M, Foerst JR, Kelm M, Kaplan AV, Virmani R, Ball T. The complementary role of microCT and histopathology in characterizing the natural history of stented arteries. Expert Rev Cardiovasc Ther. 2011 Jul;9(7):939-48. doi: 10.1586/erc.11.81.

Reference Type: BACKGROUND

PMID: 21809975 (View on PubMed)

Chen X, Ba Y, Ma L, Cai X, Yin Y, Wang K, Guo J, Zhang Y, Chen J, Guo X, Li Q, Li X, Wang W, Zhang Y, Wang J, Jiang X, Xiang Y, Xu C, Zheng P, Zhang J, Li R, Zhang H, Shang X, Gong T, Ning G, Wang J, Zen K, Zhang J, Zhang CY. Characterization of microRNAs in serum: a novel class of biomarkers for diagnosis of cancer and other diseases. Cell Res. 2008 Oct;18(10):997-1006. doi: 10.1038/cr.2008.282.

Reference Type: BACKGROUND

PMID: 18766170 (View on PubMed)

Navickas R, Gal D, Laucevicius A, Taparauskaite A, Zdanyte M, Holvoet P. Identifying circulating microRNAs as biomarkers of cardiovascular disease: a systematic review. Cardiovasc Res. 2016 Sep;111(4):322-37. doi: 10.1093/cvr/cvw174. Epub 2016 Jun 29.

Reference Type: BACKGROUND

PMID: 27357636 (View on PubMed)

Other Identifiers

20181028

Identifier Type: -

Identifier Source: org_study_id