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

NCT03429608 | Completed

• 1 other identifier: 20170210
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (3)

• volume of aspirated thrombus burden

  The volume of aspirated thrombi will be quantified using micro-CT.

  12 months

• density of aspirated thrombus burden

  The density of aspirated thrombi will be quantified using micro-CT.

  12 months

• MACCE-free survival

  Time between the date of diagnosis and MACCE during the follow-up period of 12 months. MACCE are defined as any of the following: cardiac death, cerebrovascular death, acute myocardial infarction, target lesion revascularization, stent thrombosis or stroke.

  12 months

Secondary Outcomes (14)

• association between thrombus volume with factors from patients medical history

  12 months

• association between thrombus density with factors from patients medical history

  12 months

• Correlation of the volume of aspirated thrombus burden with the Sianos' classification of thrombus burden

  12 months

• Correlation of thrombus density with the Sianos' classification of thrombus burden

  12 months

• association of thrombus volume with electrocardiographic outcomes suggestive of poor patient prognosis

  12 months

Study Arms (2)

patients with low thrombus burden

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

patients with high thrombus burden

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

consecutive patients presenting with ST elevation myocardial infarction, who undergo primary PCI and thrombus aspiration

You may qualify if:

• Patients presenting 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
• Age\>18 years
• Written informed consent prior to enrolment in the clinical trial

You may not qualify if:

• 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

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Hellenic Centre for Marine Research: collaborator
• Harvard Medical School (HMS and HSDM): collaborator
• MHAT Hadji Dimitar Hospital, Sliven, Bulgaria: collaborator

Study Sites (1)

University General Hospital of Thessaloniki AHEPA

Thessaloniki, 54636, Greece

Location

Related Publications (6)

• 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.

  PMID: 17692740 BACKGROUND

• Sianos G, Papafaklis MI, Serruys PW. Angiographic thrombus burden classification in patients with ST-segment elevation myocardial infarction treated with percutaneous coronary intervention. J Invasive Cardiol. 2010 Oct;22(10 Suppl B):6B-14B.

  PMID: 20947930 BACKGROUND

• Gibson CM, de Lemos JA, Murphy SA, Marble SJ, McCabe CH, Cannon CP, Antman EM, Braunwald E; TIMI Study Group. Combination therapy with abciximab reduces angiographically evident thrombus in acute myocardial infarction: a TIMI 14 substudy. Circulation. 2001 May 29;103(21):2550-4. doi: 10.1161/01.cir.103.21.2550.

  PMID: 11382722 BACKGROUND

• Elgendy IY, Huo T, Bhatt DL, Bavry AA. Is Aspiration Thrombectomy Beneficial in Patients Undergoing Primary Percutaneous Coronary Intervention? Meta-Analysis of Randomized Trials. Circ Cardiovasc Interv. 2015 Jul;8(7):e002258. doi: 10.1161/CIRCINTERVENTIONS.114.002258.

  PMID: 26175531 BACKGROUND

• Karagiannidis E, Papazoglou AS, Sofidis G, Chatzinikolaou E, Keklikoglou K, Panteris E, Kartas A, Stalikas N, Zegkos T, Girtovitis F, Moysidis DV, Stefanopoulos L, Koupidis K, Hadjimiltiades S, Giannakoulas G, Arvanitidis C, Michaelson JS, Karvounis H, Sianos G. Micro-CT-Based Quantification of Extracted Thrombus Burden Characteristics and Association With Angiographic Outcomes in Patients With ST-Elevation Myocardial Infarction: The QUEST-STEMI Study. Front Cardiovasc Med. 2021 Apr 21;8:646064. doi: 10.3389/fcvm.2021.646064. eCollection 2021.

  PMID: 33969012 DERIVED

• Karagiannidis E, Konstantinidis NV, Sofidis G, Chatzinikolaou E, Sianos G. Rationale and design of a prospective, observational study for the QUantitative EStimation of Thrombus burden in patients with ST-Elevation Myocardial Infarction using micro-computed tomography: the QUEST-STEMI trial. BMC Cardiovasc Disord. 2020 Mar 11;20(1):125. doi: 10.1186/s12872-020-01393-5.

  PMID: 32160856 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

aspirated thrombi from patients with ST elevation myocardial infarction, who undergo primary PCI and thrombus aspiration

MeSH Terms

Conditions

ST Elevation Myocardial Infarction; Thrombosis

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Embolism and Thrombosis

Study Officials

• Georgios Sianos, MD,PhD, FESC

  Associate Professor of Cardiology, School of Medicine, Aristotle University of Thessaloniki

  STUDY CHAIR

• Efstratios Karagiannidis, MD,MSc

  Phd candidate, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Charalambos Karvounis, MD,Phd

  Professor of Cardiology, School of Medicine, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

• George Giannakoulas, MD,Phd

  Assistant Professor of Cardiology, School of Medicine, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Christos Arvanitidis, Phd

  Director of Research, Hellenic Center for Marine Research

  PRINCIPAL INVESTIGATOR

• Ioannis Vizirianakis, PharmD, PhD

  Associate Professor, School of Pharmacy, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

• James S Michaelson, MD,Phd

  Associate Professor, Department of Pathology, Harvard Medical School

  PRINCIPAL INVESTIGATOR

• Kleoniki Keklikoglou, MSc

  HELLENIC CENTER FOR MARINE RESEARCH

  PRINCIPAL INVESTIGATOR

• Ivelin Samra, MD

  Head of cardiology department at MHAT"Hadzy Dimityr" Sliven

  PRINCIPAL INVESTIGATOR

• Nikolaos Konstantinidis, MD,MSc

  Phd candidate, Aristotle University of Thessaloniki

  PRINCIPAL INVESTIGATOR

• Georgios Sofidis, MD,Phd

  Aristotle University Of Thessaloniki

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MSc, Phd candidate

Study Record Dates

• First Submitted: January 25, 2018
• First Posted: February 12, 2018
• Study Start: January 25, 2018
• Primary Completion: July 7, 2020
• Study Completion: July 7, 2020
• Last Updated: July 8, 2020

Record last verified: 2020-07

Locations

GR (1)