Cardiovascular DiseasesMeta-SMuRFNCT05494151
Metabolic Substrate of Patients With Myocardial Infarction With and Without Modifiable Cardiovascular Risk Factors
An observational study of Cardiovascular Diseases and Acute Myocardial Infarction, run by Aristotle University Of Thessaloniki.
Trial summary
Coronary heart disease (CHD) is the leading cause of mortality worldwide. Every year, millions of people suffer its most adverse manifestation, an acute myocardial infraction (AMI). The majority of these patients present at least one of the standard modifiable risk factors (SMuRFs). Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Cardiovascular Diseases, Acute Myocardial Infarction, Acute Coronary Syndrome
- What is being tested?
- Investigation of the metabolic substrate
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2022to 1 Sep 2026
- 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 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients >25years old presenting with acute myocardial infraction with or without ST elevation within the previous 4 weeks, with at least one angiographically-testified stenosis>50% in a major epicardial coronary artery
Who may be able to join
- Age >25 years
- Hospitalization for acute myocardial infarction (AMI) with or without ST elevation (based on Fourth Universal Definition of Myocardial Infarction) within the previous 4 weeks
- Coronary angiography before or after hospitalization for AMI, in which at least one stenosis >50% in a major epicardial coronary artery (left anterior descending artery, left circumflex artery, right coronary artery) or a branch thereof with a diameter of at least 2 mm was observed.
Who cannot join
- Inability or refusal to provide informed consent
- Age >80 years
- History of hospitalization due to AMI prior to the present AMI
- History of coronary revascularization prior to the present AMI AMI
- Previous coronary angiography (prior to the present AMI) showing >50% stenosis in a major epicardial coronary artery
- Known history of hypertension and/or antihypertensive treatment prior to AMI
Show all 9Show fewer
- Use of tobacco products on a systematic basis for up to <12 months before AMI
- History of diabetes mellitus type 1 or 2 and/or treatment with antidiabetic tablets or insulin before AMI or diagnosis of diabetes mellitus based on HbA1c during AMI hospitalization
- Known hypercholesterolemia (total chol >200 mg/dl / LDLc >150 mg/dl) or treatment with statins or PCSK9is, before AMI
About this study
Official title: Investigation of the Metabolic Substrate of Patients With Myocardial Infarction and Derivation of a Risk Estimation Algorithm to Evaluate Cardiovascular Risk Beyond Standard Modifiable Risk Factors (SMuRFs) - (The MetaSMuRF Study)
Coronary heart disease (CHD) is the leading cause of mortality worldwide. Every year, millions of people suffer its most adverse manifestation, an acute myocardial infraction (AMI). The majority of these patients present at least one of the standard modifiable risk factors (SMuRFs). These include smoking, hypertension, dyslipidemia, and diabetes mellitus (DM). However, emerging scientific evidence recognizes a clinically significant proportion of patients presenting with life-threatening AMI without any SMuRF (SMuRF-less patients). This proportion of patients with ACS without SMuRF appears to be increasing during the last two decades and has recently been reported as high as 20% (of total AMIs). To date, there are no scientific data capable of highlighting specific risk factors-biomarkers responsible for the development of AMIs SMuRF-less patients. Concurrently, metabolomics is rapidly evolving as a novel technique of studying small molecule substrates, intermediates and products of cell metabolism. This technique could be utilized to flag patients with higher risk for increased atherosclerotic burden, and subsequent future adverse clinical events. Besides the already established biomarkers, several metabolomic indicators, such as ceramides (C16, C18 και C24), acylcarnitines, apolipoproteins (ApoΒ and ApoA1) and adiponectin, have been separately shown to increase the risk for coronary artery disease development and progression. Therefore, the two groups of patients (with SMuRFs vs SMuRF-less) will be compared regarding their metabolic fingerprints -specifically the aforementioned novel metabolomic biomarkers- and possible predictive factors leading to SMuRF-less AMI will be evaluated. On the basis of the above, the aim is to prospectively analyze a cohort of well-characterized patients with AMI. The rationale of the study is to investigate potential correlations between metabolic profile of patients and SMuRF-less AMI. This could lead to the development of predictive risk stratification algorithms for patients without SMuRFs and coronary artery disease.
Read the detailed description
Coronary heart disease (CHD) is the leading cause of mortality worldwide. Every year, millions of people suffer its most adverse manifestation, an acute myocardial infraction (AMI). The majority of these patients present at least one of the standard modifiable risk factors (SMuRFs). These include smoking, hypertension, dyslipidemia, and diabetes mellitus (DM). However, emerging scientific evidence recognizes a clinically significant proportion of patients presenting with life-threatening AMI without any SMuRF (SMuRF-less patients). This proportion of patients with ACS without SMuRF appears to be increasing during the last two decades and has recently been reported as high as 20% (of total AMIs). To date, there are no scientific data capable of highlighting specific risk factors-biomarkers responsible for the development of AMIs SMuRF-less patients.
Concurrently, metabolomics is rapidly evolving as a novel technique of studying small molecule substrates, intermediates and products of cell metabolism. This technique could be utilized to flag patients with higher risk for increased atherosclerotic burden, and subsequent future adverse clinical events. Besides the already established biomarkers, several metabolomic indicators, such as ceramides (C16, C18 και C24), acylcarnitines, apolipoproteins (ApoΒ and ApoA1) and adiponectin, have been separately shown to increase the risk for coronary artery disease development and progression. Therefore, the two groups of patients (with SMuRFs vs SMuRF-less) will be compared regarding their metabolic fingerprints -specifically the aforementioned novel metabolomic biomarkers- and possible predictive factors leading to SMuRF-less AMI will be evaluated. On the basis of the above, the aim is to prospectively analyze a cohort of well-characterized patients with AMI. The rationale of the study is to investigate potential correlations between metabolic profile of patients and SMuRF-less AMI. This could lead to the development of predictive risk stratification algorithms for patients without SMuRFs and coronary artery disease.
Blood tests (blood chemistry) will be received from each patient on admission and will be analyzed to assess patients' metabolic profile. In order to achieve full coverage of all compounds, different analytical platforms and methods, such as Enzyme-LInked Immunosorbent Assay (ELISA), Reversed Phase Liquid Chromatography tandem Mass Spectrometry (RPLC-MS/MS) and Hydrophilic Interaction Liquid Chromatography tandem Mass Spectrometry (HILIC-MS/MS) will be applied. Univariate and multivariate analysis with linear and logistic regression models will be used to investigate independent prognostic factors contributing to the occurrence of SMuRF-less AMIs. The potential application in daily clinical practice of a derived clinical predictive model-algorithm, possibly including a new panel of metabolomic biomarkers, will contribute to the early prognosis and personalized prevention of such a particular category of AMIs.
- Conditions
- Cardiovascular Diseases, Acute Myocardial Infarction, Acute Coronary Syndrome, Metabolic Disturbance
- Being tested
- Investigation of the metabolic substrate
- Keywords
- Myocardial Infarction, Acute Coronary Syndrome, Standard modifiable risk factor, Metabolomic biomarkers
- Medical subject headings
- Cardiovascular Diseases, Acute Coronary Syndrome, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigation of the metabolic substrateDiagnostic test
A blood sample will be received from each patient to assess novel metabolomic biomarkers' levels at the time of acute myocardial infraction
| Study group | Role | What they receive |
|---|---|---|
| SMuRFs | Patients with acute myocardial infraction with a history of at least one standard modifiable risk factor (SMuRF; smoking, diabetes mellitus, dyslipidemia, hypertension) Receives: Diagnostic Test: Investigation of the metabolic substrate | |
| SMuRF-less | Patients with acute myocardial infraction without history of any SMuRF Receives: Diagnostic Test: Investigation of the metabolic substrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolomic biomarkers associated with SMuRF-less myocardial infraction
Identification of differences in metabolomic biomarkers' levels (metabolic substrate) between SMuRF-less myocardial infractions and myocardial infractions in patients with SMuRFs
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2022
- Study start15 Oct 2022 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2026 (estimated)
Why it stopped: Due to unforeseen challenges in participant recruitment and retention, the study was early terminated to maintain the integrity of the data and ensure ethical standards were upheld.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dimitrios Moysidis, Aristotle University Of Thessaloniki
- Investigators
- Dimitrios Moysidis, Study chair, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05494151
- Sponsor's protocol ID
- 64000/20-4-2022
- Acronym
- Meta-SMuRF
- Status last verified
- Aug 2024
- First submitted
- 6 Aug 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Metabolic Substrate of Patients With Myocardial Infarction and Derivation of a Risk Estimation Algorithm to Evaluate Cardiovascular Risk Beyond Standard Modifiable Risk Factors (SMuRFs) - (The MetaSMuRF Study)
- ClinicalTrials.gov ID
- NCT05494151
- Acronym / sponsor ID
- Meta-SMuRF / 64000/20-4-2022
- Conditions
- Cardiovascular Diseases, Acute Myocardial Infarction, Acute Coronary Syndrome, Metabolic Disturbance
- Keywords
- Myocardial Infarction, Acute Coronary Syndrome, Standard modifiable risk factor, Metabolomic biomarkers
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Due to unforeseen challenges in participant recruitment and retention, the study was early terminated to maintain the integrity of the data and ensure ethical standards were upheld.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- 15 Oct 2022 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 9 Aug 2022 (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.
Coronary heart disease (CHD) is the leading cause of mortality worldwide. Every year, millions of people suffer its most adverse manifestation, an acute myocardial infraction (AMI). The majority of these patients present at least one of the standard modifiable risk factors (SMuRFs). These include smoking, hypertension, dyslipidemia, and diabetes mellitus (DM). However, emerging scientific evidence recognizes a clinically significant proportion of patients presenting with life-threatening AMI without any SMuRF (SMuRF-less patients). This proportion of patients with ACS without SMuRF appears to be increasing during the last two decades and has recently been reported as high as 20% (of total AMIs). To date, there are no scientific data capable of highlighting specific risk factors-biomarkers responsible for the development of AMIs SMuRF-less patients. Concurrently, metabolomics is rapidly evolving as a novel technique of studying small molecule substrates, intermediates and products of cell metabolism. This technique could be utilized to flag patients with higher risk for increased atherosclerotic burden, and subsequent future adverse clinical events. Besides the already established biomarkers, several metabolomic indicators, such as ceramides (C16, C18 και C24), acylcarnitines, apolipoproteins (ApoΒ and ApoA1) and adiponectin, have been separately shown to increase the risk for coronary artery disease development and progression. Therefore, the two groups of patients (with SMuRFs vs SMuRF-less) will be compared regarding their metabolic fingerprints -specifically the aforementioned novel metabolomic biomarkers- and possible predictive factors leading to SMuRF-less AMI will be evaluated. On the basis of the above, the aim is to prospectively analyze a cohort of well-characterized patients with AMI. The rationale of the study is to investigate potential correlations between metabolic profile of patients and SMuRF-less AMI. This could lead to the development of predictive risk stratification algorithms for patients without SMuRFs and coronary artery disease.
Detailed description
Coronary heart disease (CHD) is the leading cause of mortality worldwide. Every year, millions of people suffer its most adverse manifestation, an acute myocardial infraction (AMI). The majority of these patients present at least one of the standard modifiable risk factors (SMuRFs). These include smoking, hypertension, dyslipidemia, and diabetes mellitus (DM). However, emerging scientific evidence recognizes a clinically significant proportion of patients presenting with life-threatening AMI without any SMuRF (SMuRF-less patients). This proportion of patients with ACS without SMuRF appears to be increasing during the last two decades and has recently been reported as high as 20% (of total AMIs). To date, there are no scientific data capable of highlighting specific risk factors-biomarkers responsible for the development of AMIs SMuRF-less patients.
Concurrently, metabolomics is rapidly evolving as a novel technique of studying small molecule substrates, intermediates and products of cell metabolism. This technique could be utilized to flag patients with higher risk for increased atherosclerotic burden, and subsequent future adverse clinical events. Besides the already established biomarkers, several metabolomic indicators, such as ceramides (C16, C18 και C24), acylcarnitines, apolipoproteins (ApoΒ and ApoA1) and adiponectin, have been separately shown to increase the risk for coronary artery disease development and progression. Therefore, the two groups of patients (with SMuRFs vs SMuRF-less) will be compared regarding their metabolic fingerprints -specifically the aforementioned novel metabolomic biomarkers- and possible predictive factors leading to SMuRF-less AMI will be evaluated. On the basis of the above, the aim is to prospectively analyze a cohort of well-characterized patients with AMI. The rationale of the study is to investigate potential correlations between metabolic profile of patients and SMuRF-less AMI. This could lead to the development of predictive risk stratification algorithms for patients without SMuRFs and coronary artery disease.
Blood tests (blood chemistry) will be received from each patient on admission and will be analyzed to assess patients' metabolic profile. In order to achieve full coverage of all compounds, different analytical platforms and methods, such as Enzyme-LInked Immunosorbent Assay (ELISA), Reversed Phase Liquid Chromatography tandem Mass Spectrometry (RPLC-MS/MS) and Hydrophilic Interaction Liquid Chromatography tandem Mass Spectrometry (HILIC-MS/MS) will be applied. Univariate and multivariate analysis with linear and logistic regression models will be used to investigate independent prognostic factors contributing to the occurrence of SMuRF-less AMIs. The potential application in daily clinical practice of a derived clinical predictive model-algorithm, possibly including a new panel of metabolomic biomarkers, will contribute to the early prognosis and personalized prevention of such a particular category of AMIs.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMuRFs | – | Diagnostic Test: Investigation of the metabolic substratePatients with acute myocardial infraction with a history of at least one standard modifiable risk factor (SMuRF; smoking, diabetes mellitus, dyslipidemia, hypertension) |
| SMuRF-less | – | Diagnostic Test: Investigation of the metabolic substratePatients with acute myocardial infraction without history of any SMuRF |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients >25years old presenting with acute myocardial infraction with or without ST elevation within the previous 4 weeks, with at least one angiographically-testified stenosis>50% in a major epicardial coronary artery
Key inclusion criteria (3 listed)
- Age >25 years
- Hospitalization for acute myocardial infarction (AMI) with or without ST elevation (based on Fourth Universal Definition of Myocardial Infarction) within the previous 4 weeks
- Coronary angiography before or after hospitalization for AMI, in which at least one stenosis >50% in a major epicardial coronary artery (left anterior descending artery, left circumflex artery, right coronary artery) or a branch thereof with a diameter of at least 2 mm was observed.
Key exclusion criteria (9 listed)
- Inability or refusal to provide informed consent
- Age >80 years
- History of hospitalization due to AMI prior to the present AMI
- History of coronary revascularization prior to the present AMI AMI
- Previous coronary angiography (prior to the present AMI) showing >50% stenosis in a major epicardial coronary artery
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 |
|---|---|---|
| Investigation of the metabolic substrateA blood sample will be received from each patient to assess novel metabolomic biomarkers' levels at the time of acute myocardial infraction | Diagnostic test | SMuRF-less, SMuRFs |
Primary outcome
Metabolomic biomarkers associated with SMuRF-less myocardial infraction
Time frame: 3 years
Identification of differences in metabolomic biomarkers' levels (metabolic substrate) between SMuRF-less myocardial infractions and myocardial infractions in patients with SMuRFs
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 23 Aug 2024.
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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.
Dimitrios Moysidis study chair
Aristotle University Of Thessaloniki
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Acute Myocardial Infarction, run by Aristotle University Of Thessaloniki.
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 9 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 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Metabolomic biomarkers associated with SMuRF-less myocardial infraction (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Aug 2024.