Cardiovascular DiseasesCLEAR-AMINCT05791916
Novel Biomarkers in Patients With Acute Myocardial Infarction
An observational study of Cardiovascular Diseases and Myocardial Infarction, run by Aristotle University Of Thessaloniki at 2 sites in Greece.
Trial summary
This study seeks to investigate the clinical value of novel biomarkers and echocardiographic indices, including myocardial work parameters, in patients with first acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Myocardial Infarction, Acute Coronary Syndrome
- How many people
- 500 participants
- Where
- 2 sitesGreece
- Study dates
- 10 Mar 2022to Feb 2025
- How long will I take part?
- 24 Months
- 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: This study will enroll consecutive patients admitted to the First Department of Cardiology of AHEPA University General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece with first Acute Myocardial Infarction with or without ST elevation, as defined by the Fourth Universal Definition of Myocardial Infarction.
Who may be able to join
- Patients older than 18 years
- Patients acutely admitted at the Department of Cardiology of AHEPA University General Hospital, Thessaloniki, Greece with Acute Myocardial Infarction, as those are defined by the Fourth Universal Definition of Myocardial Infarction.
- Patients without known history of coronary artery disease
Who cannot join
- Patients < 18 years old at time of coronary angiography
- Patients with a previous history of coronary artery disease and/or prior revascularization
- Inability or refusal to provide informed consent
- Subject is pregnant and/or breastfeeding or intends to become pregnant during the study
Trial locations and contacts
2 sites in 1 country.
Greece2 sites, 2 recruiting
- Recruiting
AHEPA University Hospital, Thessaloniki, Greece
Thessaloniki, Central Macedonia, 54621
Stylianos Daios, MD, MSc, 6947529606 ext. +30, stylianoschrys.daios@gmail.com
Vasileios Anastasiou, MD, MSc, 6978223907 ext. +30, vasianas44@gmail.com
- Recruiting
AHEPA University Hospital, Thessaloniki, Greece
Thessaloniki, Central Macedonia, 54621
Stylianos Daios, MD, MSc, +306947529606 ext. +30§, stylianoschrys.daios@gmail.com
Vasileios Anastasiou, MD, MSc, 6978223907 ext. +30, vasianas44@gmail.com
About this study
Official title: Clinical, Laboratory and Echocardiographic Assessment of Biomarkers in Patients With Acute Myocardial Infarction
This study seeks to investigate the clinical value of novel biomarkers and echocardiographic indices, including myocardial work parameters, in patients with first acute myocardial infarction. The relationship between novel echocardiographic indices with clinical data, biochemical data in different myocardial infarction types will be attempted. Prognostic implications of those indices will be explored.
Read the detailed description
This study is a prospective registry designed to evaluate and explore novel associations and prognostic tools in patients with first Acute Myocardial Infarction (AMI) with or without ST elevation, as defined by the Fourth Universal Definition of Myocardial Infarction. All eligible adult patients admitted to the Department of Cardiology at AHEPA University General Hospital of Thessaloniki with AMI will be invited to participate.
Following revascularization, a complete and comprehensive medical interview will be conducted for each patient, during which demographic characteristics, baseline medical history, medical therapy upon admission and discharge, primary aetiology, and clinical presentation of hospitalization will be recorded. Laboratory data will be collected on admission and during hospitalization, including complete blood count, biochemical control, coagulation mechanism control, hormonal control, lipid profile including Lp(a), HbA1c, N-terminal pro-B-type natriuretic peptide plasma, higher-peak value of HsTnT, IL-6, and suPAR levels on admission.
A comprehensive transthoracic echocardiographic assessment (TTE) will be performed within 24-48 hours from revascularization to evaluate the cardiac function of patients. The TTE will include 2-dimensional-speckle-tracking analysis of all cardiac chambers and non-invasive calculation of myocardial work of the left and right ventricles. The clinical value and prognostic implications of these echocardiographic indices will also be investigated during follow-up.
The primary objective is to identify novel prognostic tools by examining the association between echocardiographic indices, clinical, and biochemical data. The study aims to contribute to a better understanding of the pathophysiology of this condition and the development of effective management strategies. By comprehensively assessing the clinical, biochemical, and echocardiographic features of patients with AMI, this study will help to establish a foundation for developing targeted and effective treatments for AMI patients.
- Conditions
- Cardiovascular Diseases, Myocardial Infarction, Acute Coronary Syndrome, Biochemical Dysfunction
- Keywords
- Acute Coronary Syndrome, Myocardial Infarction, Echocardiography, Myocardial Work, Biomarkers
- Medical subject headings
- Cardiovascular Diseases, Myocardial Infarction, Acute Coronary Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between clinical, laboratory and echocardiographic biomarkers
Clinical, laboratory, conventional and novel echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers.
Measured: 24 months
Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients
Clinical, laboratory, and echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers.
Different units of measure in this outcome do not represent different outcome measures. All clinical, laboratory and echocardiographic measurements will be evaluated separately in their own unit of measurement to assess potential prognostic biomarkers in patients with acute myocardial infarction. This does not render the measurement of each parameter a different clinical outcome.
Measured: 24 months
Secondary outcomes (5)
All-cause mortality
Death by any cause
Measured: 24 months
Cardiovascular mortality
Death directly attributed to the primary disease
Measured: 24 months
Heart Failure hospitalization
Hospitalization due to heart failure
Measured: 24 months
Acute Coronary syndrome
Acute Coronary Syndrome including Myocardial Infarction with or without ST elevation and Unstable Angina
Measured: 24 months
MACE
Composite of all-cause mortality, non-fatal acute coronary syndrome and heart failure hospitalization
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start10 Mar 2022
- Primary completion10 Dec 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 24 Months
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonios Ziakas, MD, PhD, Study director, School of Medicine, Aristotle University of ThessalonikiChristos Savopoulos, MD, PhD, Study chair, School of Medicine, Aristotle University of ThessalonikiVasileios Kamperidis, MD, MSc, PhD, Principal investigator, School of Medicine, Aristotle University of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791916
- Sponsor's protocol ID
- 3456/20
- Acronym
- CLEAR-AMI
- Status last verified
- Feb 2024
- First submitted
- 18 Mar 2023
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Daios S, Anastasiou V, Moysidis DV, Didagelos M, Papazoglou AS, Stalikas N, Zegkos T, Karagiannidis E, Skoura L, Kaiafa G, Makedou K, Ziakas A, Savopoulos C, Kamperidis V. Prognostic Implications of Clinical, Laboratory and Echocardiographic Biomarkers in Patients with Acute Myocardial Infarction-Rationale and Design of the ''CLEAR-AMI Study''. J Clin Med. 2023 Sep 2;12(17):5726. doi: 10.3390/jcm12175726.
PubMed 37685793
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical, Laboratory and Echocardiographic Assessment of Biomarkers in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05791916
- Acronym / sponsor ID
- CLEAR-AMI / 3456/20
- Conditions
- Cardiovascular Diseases, Myocardial Infarction, Acute Coronary Syndrome, Biochemical Dysfunction
- Keywords
- Acute Coronary Syndrome, Myocardial Infarction, Echocardiography, Myocardial Work, Biomarkers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 10 Dec 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 30 Mar 2023 (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.
This study seeks to investigate the clinical value of novel biomarkers and echocardiographic indices, including myocardial work parameters, in patients with first acute myocardial infarction. The relationship between novel echocardiographic indices with clinical data, biochemical data in different myocardial infarction types will be attempted. Prognostic implications of those indices will be explored.
Detailed description
This study is a prospective registry designed to evaluate and explore novel associations and prognostic tools in patients with first Acute Myocardial Infarction (AMI) with or without ST elevation, as defined by the Fourth Universal Definition of Myocardial Infarction. All eligible adult patients admitted to the Department of Cardiology at AHEPA University General Hospital of Thessaloniki with AMI will be invited to participate.
Following revascularization, a complete and comprehensive medical interview will be conducted for each patient, during which demographic characteristics, baseline medical history, medical therapy upon admission and discharge, primary aetiology, and clinical presentation of hospitalization will be recorded. Laboratory data will be collected on admission and during hospitalization, including complete blood count, biochemical control, coagulation mechanism control, hormonal control, lipid profile including Lp(a), HbA1c, N-terminal pro-B-type natriuretic peptide plasma, higher-peak value of HsTnT, IL-6, and suPAR levels on admission.
A comprehensive transthoracic echocardiographic assessment (TTE) will be performed within 24-48 hours from revascularization to evaluate the cardiac function of patients. The TTE will include 2-dimensional-speckle-tracking analysis of all cardiac chambers and non-invasive calculation of myocardial work of the left and right ventricles. The clinical value and prognostic implications of these echocardiographic indices will also be investigated during follow-up.
The primary objective is to identify novel prognostic tools by examining the association between echocardiographic indices, clinical, and biochemical data. The study aims to contribute to a better understanding of the pathophysiology of this condition and the development of effective management strategies. By comprehensively assessing the clinical, biochemical, and echocardiographic features of patients with AMI, this study will help to establish a foundation for developing targeted and effective treatments for AMI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 24 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study will enroll consecutive patients admitted to the First Department of Cardiology of AHEPA University General Hospital, Aristotle University of Thessaloniki, Thessaloniki, Greece with first Acute Myocardial Infarction with or without ST elevation, as defined by the Fourth Universal Definition of Myocardial Infarction.
Key inclusion criteria (3 listed)
- Patients older than 18 years
- Patients acutely admitted at the Department of Cardiology of AHEPA University General Hospital, Thessaloniki, Greece with Acute Myocardial Infarction, as those are defined by the Fourth Universal Definition of Myocardial Infarction.
- Patients without known history of coronary artery disease
Key exclusion criteria (4 listed)
- Patients < 18 years old at time of coronary angiography
- Patients with a previous history of coronary artery disease and/or prior revascularization
- Inability or refusal to provide informed consent
- Subject is pregnant and/or breastfeeding or intends to become pregnant during the study
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
Relationship between clinical, laboratory and echocardiographic biomarkers
Time frame: 24 months
Clinical, laboratory, conventional and novel echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers.
Relationship between clinical, laboratory, and echocardiographic biomarkers with short- and long-term prognosis of patients
Time frame: 24 months
Clinical, laboratory, and echocardiographic parameters including among others left ventricular myocardial work indices, right ventricular myocardial work indices, 2-dimensional speckle-tracking analysis of all cardiac chambers. Different units of measure in this outcome do not represent different outcome measures. All clinical, laboratory and echocardiographic measurements will be evaluated separately in their own unit of measurement to assess potential prognostic biomarkers in patients with acute myocardial infarction. This does not render the measurement of each parameter a different clinical outcome.
5 secondary outcomes
All-cause mortality
Time frame: 24 months
Cardiovascular mortality
Time frame: 24 months
Heart Failure hospitalization
Time frame: 24 months
Acute Coronary syndrome
Time frame: 24 months
MACE
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Derived from this study: PubMed 37685793Daios S, Anastasiou V, Moysidis DV, Didagelos M, Papazoglou AS, Stalikas N, Zegkos T, Karagiannidis E, Skoura L, Kaiafa G, Makedou K, Ziakas A, Savopoulos C, Kamperidis V. Prognostic Implications of Clinical, Laboratory and Echocardiographic Biomarkers in Patients with Acute Myocardial Infarction-Rationale and Design of the ''CLEAR-AMI Study''. J Clin Med. 2023 Sep 2;12(17):5726. doi: 10.3390/jcm12175726.
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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.
Antonios Ziakas, MD, PhD study director
School of Medicine, Aristotle University of Thessaloniki
Christos Savopoulos, MD, PhD study chair
School of Medicine, Aristotle University of Thessaloniki
Vasileios Kamperidis, MD, MSc, PhD principal investigator
School of Medicine, Aristotle University of Thessaloniki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Myocardial Infarction, run by Aristotle University Of Thessaloniki at 2 sites 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 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christos Savopoulos, MD, PhD (6944569749 ext. +30, chrisavopoulos@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship between clinical, laboratory and echocardiographic biomarkers (time frame: 24 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 NCT05791916, which also lists 1 linked publication.
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 28 Feb 2024.