STEMI - ST Elevation Myocardial InfarctionPGCA-ACSNCT03832153
Pan-Cardio-Genetics Clot Assessment in Acute Coronary Syndromes
An observational study of STEMI - ST Elevation Myocardial Infarction and Thrombi, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Thrombi, MicroRNA
- What is being tested?
- thrombus aspiration
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteGreece
- Study dates
- 20 Jan 2019to 30 Mar 2022
- 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: 210 consecutive patients presenting with STEMI and undergoing thrombus aspiration will be enrolled in the study
Who may be able to join
- 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
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.
About this study
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.
- Being tested
- thrombus aspiration
- Keywords
- Bioprinting, thrombus aspiration, micro-CT
- 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.
thrombus aspirationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| patients with low thrombus burden | patients with the lower volume of aspirated thrombi, as measured using micro-CT Receives: Procedure: thrombus aspiration | |
| patients with high thrombus burden | patients with the higher volume of aspirated thrombi, as measured using micro-CT Receives: Procedure: thrombus aspiration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fold changes of differentially-expressed microRNA from peripheral blood from patients suffering from STEMI (measured in log2 scale)
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.
Measured: 12 months
Volume of aspirated thrombus burden
The volume of aspirated thrombi will be quantified (in mm3) using micro-CT.
Measured: 12 months
Secondary outcomes (4)
Association between fold changes of microRNA expression and post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow
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).
Measured: 12 months
Association between fold changes of microRNA expression (measured in log2 scale) with distal embolization
Fold changes of differentially-expressed microRNAs (measured in log2 scale, as described above) will be correlated to distal embolization (dichotomous variable-yes/no).
Measured: 12 months
Association between fold changes of microRNAs expression and volume of aspirated thrombus.
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.
Measured: 12 months
Association between fold changes of microRNA expression and Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
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.
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 posted6 Feb 2019
- Study start20 Jan 2019
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Why it stopped: LACK OF FUNDING
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 STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Collaborators
- HELLENIC CENTER FOR MARINE RESEARCH, Harvard Medical School (HMS and HSDM), Centre for Research and Technology Hellas
- Responsible party
- Principal investigator, Karagiannidis Efstratios, Aristotle University Of Thessaloniki
- Investigators
- Georgios Sianos, Study chair, Associate Professor of Cardiology, Aristotle University of ThessalonikiIoannis Vizirianakis, Principal investigator, Associate Professor, School of Pharmacy, Aristotle University of ThessalonikiDimitrios Fatouros, Principal investigator, Associate Professor in Pharmaceutical Technology , Aristotle University of ThessalonikiEleftherios Angelis, Principal investigator, Professor in Statistics, Aristotle University of ThessalonikiChristos Arvanitidis, Principal investigator, Director of Research, Hellenic Center for Marine ResearchJames Michaelson, Principal investigator, Associate Professor, Department of Pathology, Harvard Medical SchoolAthanasios Zacharopoulos, Principal investigator, Post-Doctoral Fellow, Hellenic Center for Marine ResearchChristos Ouzounis, Principal investigator, Director of Research, Centre for Research and Technology Hellas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03832153
- Sponsor's protocol ID
- 20181028
- Acronym
- PGCA-ACS
- Status last verified
- Feb 2022
- First submitted
- 27 Jan 2019
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 17692740Ibanez 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.
PubMed 28886621Grover 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.
PubMed 26489729Vorpahl 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.
PubMed 21809975Chen 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.
PubMed 18766170Navickas 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.
PubMed 27357636
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pan-Cardio-Genetics Clot Assessment in Acute Coronary Syndromes
- ClinicalTrials.gov ID
- NCT03832153
- Acronym / sponsor ID
- PGCA-ACS / 20181028
- Keywords
- Bioprinting, thrombus aspiration, micro-CT
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: LACK OF FUNDING
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Collaborators
- HELLENIC CENTER FOR MARINE RESEARCH, Harvard Medical School (HMS and HSDM), Centre for Research and Technology Hellas
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 6 Feb 2019 (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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with low thrombus burden | – | Procedure: thrombus aspirationpatients with the lower volume of aspirated thrombi, as measured using micro-CT |
| patients with high thrombus burden | – | Procedure: thrombus aspirationpatients 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
- 210 consecutive patients presenting with STEMI and undergoing thrombus aspiration will be enrolled in the study
Key inclusion criteria (5 listed)
- 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
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thrombus aspirationThrombus 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. | Procedure or surgery | patients with high thrombus burden, patients with low thrombus burden |
Primary outcome
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.
Volume of aspirated thrombus burden
Time frame: 12 months
The volume of aspirated thrombi will be quantified (in mm3) using micro-CT.
4 secondary outcomes
Association between fold changes of microRNA expression and post-procedural Thrombolysis in Myocardial Infarction (TIMI) flow
Time frame: 12 months
Association between fold changes of microRNA expression (measured in log2 scale) with distal embolization
Time frame: 12 months
Association between fold changes of microRNAs expression and volume of aspirated thrombus.
Time frame: 12 months
Association between fold changes of microRNA expression and Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2022.
- 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 28886621Ibanez 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.
- Background: PubMed 26489729Grover 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.
- Background: PubMed 21809975Vorpahl 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.
- Background: PubMed 18766170Chen 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.
- Background: PubMed 27357636Navickas 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.
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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 study chair
Associate Professor of Cardiology, Aristotle University of Thessaloniki
Ioannis Vizirianakis principal investigator
Associate Professor, School of Pharmacy, Aristotle University of Thessaloniki
Dimitrios Fatouros principal investigator
Associate Professor in Pharmaceutical Technology , 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 STEMI - 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 5 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: withdrawn, as of the sponsor's last update on 3 Mar 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Fold changes of differentially-expressed microRNA from peripheral blood from patients suffering from STEMI (measured in log2 scale) (time frame: 12 months). The study lists 2 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 NCT03832153, 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 3 Mar 2022.