ST Elevation Myocardial InfarctionQUEST-STEMINCT03429608
Quantitative Estimation of Thrombus Burden in Patients With STEMI Using Micro-Computed Tomography (QUEST-STEMI)
An observational study of ST Elevation Myocardial Infarction and Thrombi, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST Elevation Myocardial Infarction, Thrombi
- How many people
- 115 participants
- Where
- 1 siteGreece
- Study dates
- 25 Jan 2018to 7 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: consecutive patients presenting with ST elevation myocardial infarction, who undergo primary PCI and thrombus aspiration
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Greece1 site
University General Hospital of Thessaloniki AHEPA
Thessaloniki, 54636
About this study
Official title: Quantitative Estimation of Thrombus Burden in Patients With ST Elevation Acute Myocardial Infarction (STEMI) With the Use of Micro-computed Tomography-A Methodological Approach (QUEST-STEMI)
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:
Read more
- 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.
Read the detailed description
Acute myocardial infarction with ST elevation (STEMI) remains one of the leading causes of mortality in developed countries, in spite of the important advances in pharmacological therapy and in mechanical reperfusion therapy. Having an important role in provoking ischemia, thrombus has been studied in many clinical trials and high thrombus burden has been proven to be an independent risk factor for stent thrombosis and for Major Adverse Clinical outcomes. However large randomized controlled trials concerning thrombus aspiration showed controversial results, providing as a whole no evidence of distinct benefits for thrombus aspiration. A possible explanation could be that aspiration was performed as a routine strategy in all of these trials, whereas these patients should be considered as a heterogeneous group and thus they should be risk-stratified. For this reason, it is of paramount importance to classify patients according to the volume of thrombus burden. The currently existing classifications of thrombus burden (the most important being those of Gibson and of Sianos) are based on visual assessment of angiographic characteristics and thus they are not reflecting the volume of the thrombi in actual, absolute numbers.
The main purpose of the study is to develop a methodology for the exact estimation of thrombus burden by measuring the volume and the density of aspirated thrombi in patients presenting with STEMI and referred for primary PCI. After being aspirated using dedicated catheters, thrombi will be preserved in formalin and their volume will be calculated with the use of micro-CT. The scanning procedure results into a series of projection images arranged in the form of image stacks which, in turn, are reformed in sections (cross section images) with the use of the NRecon (Bruker, Kontich, Belgium) software, which applies a modified algorithm of backward projection Feldkamp. The resulting sections will be combined to create the 3D models which will be further analyzed to extract useful measurements for the characteristics of the thrombi, such as for the volume and the elative density. Shape analysis on the surface and internal structure of the three-dimensional representations of the specimens will lead to the identification of the important features that can be used to estimate variability within samples and perform clustering for the significant differences between clots. In addition, possible differences in clot internal and external structure (e.g. architecture of the various cell types) will be assessed through the 3D models rendered from the stacks of images The Secondary end points of the study include the examination of the association of the aforementioned variables with the angiographic classification of thrombus burden (according to Sianos), with electrocardiographic and angiographic characteristics suggestive of poor patient prognosis and with major adverse cardiac events during the follow-up period of one year.
This method could become the gold standard for the exact measurement of thrombus burden and could be used in larger, clinically-oriented trials to help stratify patients with thrombus burden according to their risk for adverse outcomes.
- Conditions
- ST Elevation Myocardial Infarction, Thrombi
- Medical subject headings
- ST Elevation Myocardial Infarction, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of aspirated thrombus burden
The volume of aspirated thrombi will be quantified using micro-CT.
Measured: 12 months
density of aspirated thrombus burden
The density of aspirated thrombi will be quantified using micro-CT.
Measured: 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.
Measured: 12 months
Secondary outcomes (14)
association between thrombus volume with factors from patients medical history
Potential association of thrombus volume (as assessed using micro-ct) with factors potentially affecting thrombus burden, including history of diabetes mellitus (dichotomous variable yes/no), use of antiplatelet drugs or anticoagulants (dichotomous variable yes/no),pain-to-balloon time (in minutes) and history of smoking (dichotomous variable yes/no) will be explored and reported.
Measured: 12 months
association between thrombus density with factors from patients medical history
Potential association of thrombus density ( as assessed using micro-CT) with factors potentially affecting thrombus burden, including history of diabetes mellitus (dichotomous variable yes/no), use of antiplatelet drugs or anticoagulants (dichotomous variable yes/no),pain-to-balloon time (in minutes) and history of smoking (dichotomous variable yes/no) will be explored and reported.
Measured: 12 months
Correlation of the volume of aspirated thrombus burden with the Sianos' classification of thrombus burden
Potential correlation of the volume of aspirated thrombus burden, as assessed using the micro-CT and the angiographic classification of thrombus burden according to Sianos will be explored. According to Sianos' classification thrombi are classified in the following categories: G0,G1,G2,G3,G4.
Measured: 12 months
Correlation of thrombus density with the Sianos' classification of thrombus burden
Potential correlation of thrombus density, as assessed using the micro-CT and the angiographic classification of thrombus burden according to Sianos will be explored.
Measured: 12 months
association of thrombus volume with electrocardiographic outcomes suggestive of poor patient prognosis
Potential association of thrombus volume as measured using micro-CT with ST segment resolution will be explored. ST resolution will be classified as complete (>70%), partial (30-70%), or absent (<30%).
Measured: 12 months
association of thrombus density with electrocardiographic outcomes suggestive of poor patient prognosis
Potential association of thrombus density as measured using micro-CT with ST segment resolution will be explored. ST resolution will be classified as complete (>70%), partial (30-70%), or absent (<30%).
Measured: 12 months
association of thrombus volume with post-procedural Thrombolysis in Myocardial Infarction(TIMI) flow
Potential association of thrombus volume as measured using micro-CT, with post-procedural TIMI flow (classified as previously described: TIMI flow 0,1,2 or 3) will be explored
Measured: 12 months
association of thrombus density with post-procedural TIMI flow
Potential association of thrombus density as measured using micro-CT, with post-procedural TIMI flow (classified as previously described: TIMI flow 0,1,2 or 3) will be explored
Measured: 12 months
association of thrombus volume with myocardial blush grade
Potential association of thrombus volume as measured using micro-CT, with myocardial blush grade (classified as previously described: myocardial blush grade 0, myocardial blush grade 1, myocardial blush grade 2 and myocardial blush grade 3) will be explored.
Measured: 12 months
association of thrombus density with myocardial blush grade
Potential association of thrombus density as measured using micro-CT, with myocardial blush grade (classified as previously described: myocardial blush grade 0, myocardial blush grade 1, myocardial blush grade 2 and myocardial blush grade 3) will be explored.
Measured: 12 months
association of thrombus volume with distal embolization .
Potential association of thrombus volume as measured using micro-CT, with distal embolization (dichotomous variable yes/no) will be explored.
Measured: 12 months
association of thrombus density with distal embolization .
Potential association of thrombus density as measured using micro-CT, with distal embolization (dichotomous variable yes/no) will be explored.
Measured: 12 months
association of thrombus volume with Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Potential association of thrombus volume, as measured using micro-CT with MACCE during the follow-up period of 12 months, will be explored. MACCE are defined as any of the following: cardiac death, cerebrovascular death, acute myocardial infarction, target lesion revascularization, stent thrombosis or stroke.
Measured: 12 months
association of thrombus density with Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Potential association of thrombus density, as measured using micro-CT with MACCE during the follow-up period of 12 months, will be explored. MACCE are defined as any of the following: cardiac death, cerebrovascular death, acute myocardial infarction, target lesion revascularization, stent thrombosis or stroke.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start25 Jan 2018
- Primary completion7 Jul 2020
- Study completion7 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- Hellenic Centre for Marine Research, Harvard Medical School (HMS and HSDM), MHAT Hadji Dimitar Hospital, Sliven, Bulgaria
- Responsible party
- Principal investigator, Karagiannidis Efstratios, Aristotle University Of Thessaloniki
- Investigators
- Georgios Sianos, MD,PhD, FESC, Study chair, Associate Professor of Cardiology, School of Medicine, Aristotle University of ThessalonikiEfstratios Karagiannidis, MD,MSc, Principal investigator, Phd candidate, Aristotle University of ThessalonikiCharalambos Karvounis, MD,Phd, Principal investigator, Professor of Cardiology, School of Medicine, Aristotle University of ThessalonikiGeorge Giannakoulas, MD,Phd, Principal investigator, Assistant Professor of Cardiology, School of Medicine, Aristotle University of ThessalonikiChristos Arvanitidis, Phd, Principal investigator, Director of Research, Hellenic Center for Marine ResearchIoannis Vizirianakis, PharmD, PhD, Principal investigator, Associate Professor, School of Pharmacy, Aristotle University of ThessalonikiJames S Michaelson, MD,Phd, Principal investigator, Associate Professor, Department of Pathology, Harvard Medical SchoolKleoniki Keklikoglou, MSc, Principal investigator, HELLENIC CENTER FOR MARINE RESEARCH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429608
- Sponsor's protocol ID
- 20170210
- Acronym
- QUEST-STEMI
- Status last verified
- Jul 2020
- First submitted
- 25 Jan 2018
- Last updated
- 8 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision to share or not individual participant data with other researchers will depend on the purpose and the scope of the proposed research
Publications
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.
PubMed 17692740Sianos 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.
PubMed 20947930Gibson 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.
PubMed 11382722Elgendy 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.
PubMed 26175531Karagiannidis 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.
PubMed 33969012Karagiannidis 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.
PubMed 32160856
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Estimation of Thrombus Burden in Patients With ST Elevation Acute Myocardial Infarction (STEMI) With the Use of Micro-computed Tomography-A Methodological Approach (QUEST-STEMI)
- ClinicalTrials.gov ID
- NCT03429608
- Acronym / sponsor ID
- QUEST-STEMI / 20170210
- Conditions
- ST Elevation Myocardial Infarction, Thrombi
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- Hellenic Centre for Marine Research, Harvard Medical School (HMS and HSDM), MHAT Hadji Dimitar Hospital, Sliven, Bulgaria
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 7 Jul 2020 (actual)
- Study completion
- 7 Jul 2020 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acute myocardial infarction with ST elevation (STEMI) remains one of the leading causes of mortality in developed countries, in spite of the important advances in pharmacological therapy and in mechanical reperfusion therapy. Having an important role in provoking ischemia, thrombus has been studied in many clinical trials and high thrombus burden has been proven to be an independent risk factor for stent thrombosis and for Major Adverse Clinical outcomes. However large randomized controlled trials concerning thrombus aspiration showed controversial results, providing as a whole no evidence of distinct benefits for thrombus aspiration. A possible explanation could be that aspiration was performed as a routine strategy in all of these trials, whereas these patients should be considered as a heterogeneous group and thus they should be risk-stratified. For this reason, it is of paramount importance to classify patients according to the volume of thrombus burden. The currently existing classifications of thrombus burden (the most important being those of Gibson and of Sianos) are based on visual assessment of angiographic characteristics and thus they are not reflecting the volume of the thrombi in actual, absolute numbers.
The main purpose of the study is to develop a methodology for the exact estimation of thrombus burden by measuring the volume and the density of aspirated thrombi in patients presenting with STEMI and referred for primary PCI. After being aspirated using dedicated catheters, thrombi will be preserved in formalin and their volume will be calculated with the use of micro-CT. The scanning procedure results into a series of projection images arranged in the form of image stacks which, in turn, are reformed in sections (cross section images) with the use of the NRecon (Bruker, Kontich, Belgium) software, which applies a modified algorithm of backward projection Feldkamp. The resulting sections will be combined to create the 3D models which will be further analyzed to extract useful measurements for the characteristics of the thrombi, such as for the volume and the elative density. Shape analysis on the surface and internal structure of the three-dimensional representations of the specimens will lead to the identification of the important features that can be used to estimate variability within samples and perform clustering for the significant differences between clots. In addition, possible differences in clot internal and external structure (e.g. architecture of the various cell types) will be assessed through the 3D models rendered from the stacks of images The Secondary end points of the study include the examination of the association of the aforementioned variables with the angiographic classification of thrombus burden (according to Sianos), with electrocardiographic and angiographic characteristics suggestive of poor patient prognosis and with major adverse cardiac events during the follow-up period of one year.
This method could become the gold standard for the exact measurement of thrombus burden and could be used in larger, clinically-oriented trials to help stratify patients with thrombus burden according to their risk for adverse outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- consecutive patients presenting with ST elevation myocardial infarction, who undergo primary PCI and thrombus aspiration
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
volume of aspirated thrombus burden
Time frame: 12 months
The volume of aspirated thrombi will be quantified using micro-CT.
density of aspirated thrombus burden
Time frame: 12 months
The density of aspirated thrombi will be quantified using micro-CT.
MACCE-free survival
Time frame: 12 months
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.
14 secondary outcomes
association between thrombus volume with factors from patients medical history
Time frame: 12 months
association between thrombus density with factors from patients medical history
Time frame: 12 months
Correlation of the volume of aspirated thrombus burden with the Sianos' classification of thrombus burden
Time frame: 12 months
Correlation of thrombus density with the Sianos' classification of thrombus burden
Time frame: 12 months
association of thrombus volume with electrocardiographic outcomes suggestive of poor patient prognosis
Time frame: 12 months
association of thrombus density with electrocardiographic outcomes suggestive of poor patient prognosis
Time frame: 12 months
association of thrombus volume with post-procedural Thrombolysis in Myocardial Infarction(TIMI) flow
Time frame: 12 months
association of thrombus density with post-procedural TIMI flow
Time frame: 12 months
association of thrombus volume with myocardial blush grade
Time frame: 12 months
association of thrombus density with myocardial blush grade
Time frame: 12 months
association of thrombus volume with distal embolization .
Time frame: 12 months
association of thrombus density with distal embolization .
Time frame: 12 months
association of thrombus volume with Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 12 months
association of thrombus density with Major Adverse Cardiac and Cerebrovascular Events (MACCE)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2020.
- Background: PubMed 17692740Sianos 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.
- Background: PubMed 20947930Sianos 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.
- Background: PubMed 11382722Gibson 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.
- Background: PubMed 26175531Elgendy 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.
- Derived from this study: PubMed 33969012Karagiannidis 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.
- Derived from this study: PubMed 32160856Karagiannidis 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.
- Individual participant dataSharing planned: Undecided. The decision to share or not individual participant data with other researchers will depend on the purpose and the scope of the proposed research
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Sianos, MD,PhD, FESC study chair
Associate Professor of Cardiology, School of Medicine, Aristotle University of Thessaloniki
Efstratios Karagiannidis, MD,MSc principal investigator
Phd candidate, Aristotle University of Thessaloniki
Charalambos Karvounis, MD,Phd principal investigator
Professor of Cardiology, School of Medicine, Aristotle University of Thessaloniki
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction and Thrombi, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of aspirated thrombus burden (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03429608, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2020.