Pan-Cardio-Genetics Clot Assessment in Acute Coronary Syndromes (PGCA-ACS)

February 16, 2022 updated by: Karagiannidis Efstratios, Aristotle University Of Thessaloniki
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Thessaloníki, Greece, 54636
        • Ahepa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

210 consecutive patients presenting with STEMI and undergoing thrombus aspiration will be enrolled in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients with low thrombus burden
patients with the lower volume of aspirated thrombi, as measured using micro-CT
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.
patients with high thrombus burden
patients with the higher volume of aspirated thrombi, as measured using micro-CT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fold changes of differentially-expressed microRNA from peripheral blood from patients suffering from STEMI (measured in log2 scale)
Time Frame: 12 months
The expression profiles of the total number of microRNAs that exist in the peripheral blood of patients suffering from STEMI will be analyzed using Next Generation Sequencing (NGS). Blood samples collected from the patients will be used to extract microRNAs through the application of suitable microRNA isolation kit (miRNeasy Serum/Plasma kit). Following, the miRNA library construction will be prepared using commercially available reagents (QIAseq miRNA Library kit). The quantification of miRNAs will be done by the Qubit dsDNA HS assay kit in the Qubit fluorometer before the cDNA library generation.Statistical analyses of differentially expressed miRNAs will be carried out using EdgeR by the generalized linear model. Fold changes of differentially-expressed microRNA will be measured in log2 scale.
12 months
Volume of aspirated thrombus burden
Time Frame: 12 months
The volume of aspirated thrombi will be quantified (in mm3) using micro-CT.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Association between fold changes of microRNA expression and post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow
Time Frame: 12 months
Fold changes of differentially-expressed microRNAs (measured in log2 scale as described above) will be correlated to post-procedural TIMI flow (classified as previously described: TIMI flow 0,1,2 or 3).
12 months
Association between fold changes of microRNA expression (measured in log2 scale) with distal embolization
Time Frame: 12 months
Fold changes of differentially-expressed microRNAs (measured in log2 scale, as described above) will be correlated to distal embolization (dichotomous variable-yes/no).
12 months
Association between fold changes of microRNAs expression and volume of aspirated thrombus.
Time Frame: 12 months
Fold changes of differentially-expressed microRNA (measured in log2 scale) will be correlated to the volume of aspirated thrombi (measured in mm3), as it will be quantified using micro-CT.
12 months
Association between fold changes of microRNA expression and Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time Frame: 12 months
Fold changes of differentially-expressed microRNAs (measured in log2 scale) will be correlated to MACCE. MACCE are defined as any of the following: cardiac death, cerebrovascular death, acute myocardial infarction, target lesion revascularization, stent thrombosis or stroke.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Harvard Medical School (HMS and HSDM)
Centre for Research and Technology Hellas
HELLENIC CENTER FOR MARINE RESEARCH

Investigators

  • Study Chair: Georgios Sianos, Associate Professor of Cardiology, Aristotle University of Thessaloniki
  • Principal Investigator: Ioannis Vizirianakis, Associate Professor, School of Pharmacy, Aristotle University of Thessaloniki
  • Principal Investigator: Dimitrios Fatouros, Associate Professor in Pharmaceutical Technology , Aristotle University of Thessaloniki
  • Principal Investigator: Eleftherios Angelis, Professor in Statistics, Aristotle University of Thessaloniki
  • Principal Investigator: Christos Arvanitidis, Director of Research, Hellenic Center for Marine Research
  • Principal Investigator: James Michaelson, Associate Professor, Department of Pathology, Harvard Medical School
  • Principal Investigator: Athanasios Zacharopoulos, Post-Doctoral Fellow, Hellenic Center for Marine Research
  • Principal Investigator: Christos Ouzounis, Director of Research, Centre for Research and Technology Hellas
  • Principal Investigator: Efstratios Karagiannidis, Phd Candidate, Aristotle University of Thessaloniki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Anticipated)

March 30, 2022

Study Completion (Anticipated)

March 30, 2022

Study Registration Dates

First Submitted

January 27, 2019

First Submitted That Met QC Criteria

February 5, 2019

First Posted (Actual)

February 6, 2019

Study Record Updates

Last Update Posted (Actual)

March 3, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20181028

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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