Quantitative Estimation of Thrombus Burden in Patients With STEMI Using Micro-Computed Tomography (QUEST-STEMI)

NCT03429608 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 115

Last updated 2020-07-08

No results posted yet for this study

Summary

The study aims to assess for the first time, through the application of innovative technologies (micro-CT), important characteristics of aspirated thrombi (such as their volume and their density), which might be linked to certain clinical outcomes, in patients presenting with STEMI and referred for primary Percutaneous Coronary Intervention (PCI). To this end, a methodology for the exact estimation of thrombus burden by measuring the volume and the density of aspirated thrombi will be developed. After being aspirated using dedicated catheters, thrombi will be preserved in formalin and their volume and their density will be calculated with the use of micro-CT. Having a better resolution than conventional computed tomography, micro-CT will allow us to create 3D models of aspirated thrombi from a series of x-ray projection images. These 3D models will be further analyzed in order to find the volume and the density of aspirated thrombi. Shape analysis of the surface of aspirated thrombi and potential differences in their structure will also be assessed. Correlation of these variables with clinical parameters and angiographic outcomes will be attempted.

Thus, a risk-stratification model will be developed combining:

* Clinical and laboratory data,
* Angiographic parameters,
* Data regarding the volume, the density and the composition of aspirated thrombi.

This model will enable the stratification of the cardiovascular and cerebrovascular risk of patients and the identification of who will benefit from thrombus aspiration, providing a personalized approach in treating patients with STEMI.

Conditions

  • ST Elevation Myocardial Infarction
  • Thrombi

Sponsors & Collaborators

  • Hellenic Centre for Marine Research

    collaborator UNKNOWN
  • Harvard Medical School (HMS and HSDM)

    collaborator OTHER
  • MHAT Hadji Dimitar Hospital, Sliven, Bulgaria

    collaborator UNKNOWN
  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Georgios Sianos, MD,PhD, FESC · Associate Professor of Cardiology, School of Medicine, Aristotle University of Thessaloniki

  • Efstratios Karagiannidis, MD,MSc · Phd candidate, Aristotle University of Thessaloniki

  • Charalambos Karvounis, MD,Phd · Professor of Cardiology, School of Medicine, Aristotle University of Thessaloniki

  • George Giannakoulas, MD,Phd · Assistant Professor of Cardiology, School of Medicine, Aristotle University of Thessaloniki

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

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

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

  • Kleoniki Keklikoglou, MSc · HELLENIC CENTER FOR MARINE RESEARCH

  • Ivelin Samra, MD · Head of cardiology department at MHAT"Hadzy Dimityr" Sliven

  • Nikolaos Konstantinidis, MD,MSc · Phd candidate, Aristotle University of Thessaloniki

  • Georgios Sofidis, MD,Phd · Aristotle University Of Thessaloniki

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-25
Primary Completion
2020-07-07
Completion
2020-07-07

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 NCT03429608 on ClinicalTrials.gov