Acute Coronary SyndromeMIGATERNCT03434483
The Microbiome as a Target for Precision Medicine in Atherosclerosis
An observational study of Acute Coronary Syndrome and Atherosclerosis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
Trial summary
Cardiovascular diseases are the main cause of death in industrialized countries. Among them, atherosclerosis has the highest prevalence and constitutes a common pathological pathway responsible for the majority of cases of chronic ischemic heart disease, acute myocardial infarction, heart failure and cerebrovascular… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Coronary Syndrome, Atherosclerosis
- What is being tested?
- Assessment of the atherosclerotic plaque in a moderate lession., Gene variants in atherosclerosis and Microbiota analysis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 156 participants
- Where
- 1 siteSpain
- Study dates
- 25 Feb 2018to 8 Feb 2021
- How long will I take part?
- 12 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: Acute coronary syndrome candidates for the study will be all patients with an episode of acute coronary syndrome wwho enter the Gregorio Marañón General University Hospital who meet all of the inclusion criteria and none of the exclusion criteria. Chronic atherosclerosis candidates for the study will be all patients with chronic atherosclerosis under follow-up in the General University Hospital Gregorio Marañón that meet all the following inclusion criteria and none of the exclusion criteria.
Who may be able to join
- Diagnosis of acute coronary syndrome
- Signature of informed consent for the study (Annex I).
- Angiographic diagnosis, using catheterization or computed tomography of coronary atherosclerotic disease.
- Clinical situation of stable chronic ischemic heart disease.
- Signature of informed consent for the study (Annex III).
Who cannot join
- Previous Ejection fraction of VI less than 30%.
- History of heart failure
- Systemic inflammatory diseases
- In treatment with corticosteroids or immunomodulators
- In treatment with antibiotics during the last month
- Aditional Inclusion Criteria for angiographic substudy group:
Show all 17Show fewer
- Clinical indication of coronary angiography in the acute phase (in the first 72 hours after its hospital diagnosis).
- At least one non-causal coronary lesion in a coronary segment with reference diameter> 2 mm, stenosis between 40-80%, and TIMI 3 flow in this vessel (angiographic criteria, only confirmed after performing coronary angiography)
- Signature of informed consent for the substudy (Annex II).
- Aditional Exclusion Criteria for angiographic substudy group:
- Renal insufficiency with creatinine clearance less than 30 ml / h
- Hepatic insufficiency: patients with cirrhosis in Child B or C stages will be excluded.
- Previous Ejection fraction of VI less than 30%.
- History of heart failure
- Systemic inflammatory diseases
- In treatment with corticosteroids or immunomodulators
- In treatment with antibiotics during the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microbiome, Inflammation and Genetics as a Target for Precision Medicine in AThERosclerosis
Cardiovascular diseases are the main cause of death in industrialized countries. Among them, atherosclerosis has the highest prevalence and constitutes a common pathological pathway responsible for the majority of cases of chronic ischemic heart disease, acute myocardial infarction, heart failure and cerebrovascular disease. Classic studies have confirmed well-established etiopathogenic factors of atherosclerosis based on genetic and immunological components and environmental modifying agents such as diet and exercise. But in addition, recent experimental studies have shown that dysbiosis (alteration of the microbiota) may be an additional factor that participates in the onset and progression of atherosclerosis. The objective of this study is to identify the potential interactions between changes in the microbiota, changes in the immune status, the clinical evolution and the instability and progression of atherosclerosis.
Read the detailed description
The study will prospectively study two groups of patients : 1) patients with acute coronary syndrome and 2) age and sex matched patients with chronic stable documented atherosclerosis.
Immune cell populations and immune-related metabolites will be characterized, the genetic profile of the main known functional variants will be determined, and the oral, gastrointestinal, and blood microbiota will be compared in both groups in a transversal observational design.
In addition, 1-year clinical follow-up will be performed and correlation with the evolution of the microbiota and immune response in a longitudinal design will be conducted.
Besides, an angiographic substudy, for those patients included in the study but that require revascularization of culprit artery according to clinical indication, will be 1 year follow-up and functional assessment and intravascular imaging and the degree of remodelling of the atherosclerotic plaque will be correlated with the evolution of the microbiota and immune response in a longitudinal design.
- Conditions
- Acute Coronary Syndrome, Atherosclerosis
- Being tested
- Assessment of the atherosclerotic plaque in a moderate lession., Gene variants in atherosclerosis, Microbiota analysis, Immunological analysis, Clinical evaluation
- Keywords
- Microbiota, Immunity, Genetics, Atherosclerosis
- Medical subject headings
- Acute Coronary Syndrome, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Assessment of the atherosclerotic plaque in a moderate lession.Procedure or surgery
Also called Coronary blood collection
In patients who have been successfully revascularized the artery responsible for AMI and also present an intermediate lesion (40-80%) in another coronary territory, the clinical care protocol of the Cardiology Service stipulates the need for a physiological assessment with guidance of pressure (FFR).
The thickness of the fibrous cap shall be measured using optical coherence tomography.
In addition to the FFR measurement, a complete physiological assessment with a Doppler-pressure guide. This will allow the procedure to be performed without additional risk to the patient. The physiological study will include the analysis of endothelium-dependent vascular function and endothelium-independent vascular function.
Gene variants in atherosclerosisGenetic
From the blood samples of the patients, the total DNA will be extracted and the main functional variants identified in the literature will be genotyped
Microbiota analysisOther
From the samples of blood, feces, oral cavity and blood, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons.
Immunological analysisOther
A study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
Clinical evaluationOther
Clinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration
| Study group | Role | What they receive |
|---|---|---|
| Acute Coronary Syndrome | Patients with an episode of acute coronary syndrome. Clinical evaluation 1 year. Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis. Receives: Genetic: Gene variants in atherosclerosis; Other: Microbiota analysis; Other: Immunological analysis; Other: Clinical evaluation | |
| ACS-Angiographic substudy | Patients included in the Acute Coronary Syndrome group with clinical indication for revascularization.
Clinical evaluation. Assessment of the atherosclerotic plaque in a moderate lession at baseline and 1-year .
Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis Receives: Procedure: Assessment of the atherosclerotic plaque in a moderate lession.; Genetic: Gene variants in atherosclerosis; Other: Microbiota analysis; Other: Immunological analysis; Other: Clinical evaluation | |
| Chronic coronary atherosclerosis | Patients with chronic atherosclerosis. Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis. Receives: Genetic: Gene variants in atherosclerosis; Other: Microbiota analysis; Other: Immunological analysis; Other: Clinical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in clinical evaluation at 12 months
Cardiac events register including hemostasis and biochemical determinations
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Change from baseline in fibrous cap thickness at 12 months
Angiographic substudy-Change from baseline in the thickness of the fibrous cap (μm) of an atherosclerotic plaque in the nonculprit vessel as measured using optical coherence tomography
Measured: Inclusion and 12 months
Secondary outcomes (9)
Endothelial dysfunction
Angiographic substudy-Micro and macrovascular endothelial function measured using a Doppler pressure guidewire
Measured: Inclusion and 12 months
Intestinal microbiota composition changes 16S
Changes from baseline in intestinal microbiota will be analysed using the 16S rRNA target gene sequencing approach at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Intestinal microbiota composition changes metagenome
Changes from baseline in intestinal microbiota will be analysed using the metagenome sequencing approach at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Blood microbiota composition changes 16S
Changes from baseline in blood microbiota will be analysed using the 16S rRNA target gene sequencing approach at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Blood microbiota composition changes metagenome
Changes from baseline in blood microbiota will be analysed using the metagenome sequencing approach at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Oral microbiota composition changes 16S
Changes from baseline in oral microbiota will be analysed using the 16S rRNA target gene sequencing approach at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Oral microbiota composition changes metagenome
Changes from baseline in oral microbiota will be analysed using the genome sequencing approach at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Adaptive immune system status changes
Changes from baseline of adaptive immune cell lineages will be assessed dynamically using high performance cytometry at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Innate immune system status changes
Changes from baseline of innate immune cell lineages will be assessed dynamically using high performance cytometry at 1 week, 1 month, 3 months, 6 months and 12 months
Measured: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start25 Feb 2018
- Primary completion8 Feb 2021
- Study completion8 Feb 2021
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 Acute Coronary SyndromeStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 156 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Gregorio Marañon
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Responsible party
- Principal investigator, Javier Bermejo Thomas, Hospital General Universitario Gregorio Marañon
- Investigators
- Francisco Fernández-Aviles, Prof, MD, Study director, Hospital General Universitario Gregorio Marañon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434483
- Sponsor's protocol ID
- FIBHGM-MIGATER
- Other IDs
- PIE 16/00055
- Acronym
- MIGATER
- Status last verified
- Aug 2021
- First submitted
- 8 Jan 2018
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
I Fernandez-Avila A, Gutierrez-Ibanes E, Martin de Miguel I, Sanz-Ruiz R, Gabaldon A, Fernandez-Aviles F, Gomez-Lara J, Fernandez-Castillo M, Vazquez-Cuesta S, Martinez-Legazpi P, Lozano-Garcia N, Blazquez-Lopez E, Yotti R, Lopez-Cade I, Reigadas E, Munoz P, Elizaga J, Correa R, Bermejo J. One-year longitudinal changes of peripheral CD4+ T-lymphocyte counts, gut microbiome, and plaque vulnerability after an acute coronary syndrome. Int J Cardiol Heart Vasc. 2024 Jun 4;53:101438. doi: 10.1016/j.ijcha.2024.101438. eCollection 2024 Aug.
PubMed 38912228
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microbiome, Inflammation and Genetics as a Target for Precision Medicine in AThERosclerosis
- ClinicalTrials.gov ID
- NCT03434483
- Acronym / sponsor ID
- MIGATER / FIBHGM-MIGATER
- Conditions
- Acute Coronary Syndrome, Atherosclerosis
- Keywords
- Microbiota, Immunity, Genetics, Atherosclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Hospital General Universitario Gregorio MarañonUniversity, hospital or other
- Collaborators
- Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
- Study start
- 25 Feb 2018 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- 8 Feb 2021 (actual)
- First posted
- 15 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.
Cardiovascular diseases are the main cause of death in industrialized countries. Among them, atherosclerosis has the highest prevalence and constitutes a common pathological pathway responsible for the majority of cases of chronic ischemic heart disease, acute myocardial infarction, heart failure and cerebrovascular disease. Classic studies have confirmed well-established etiopathogenic factors of atherosclerosis based on genetic and immunological components and environmental modifying agents such as diet and exercise. But in addition, recent experimental studies have shown that dysbiosis (alteration of the microbiota) may be an additional factor that participates in the onset and progression of atherosclerosis. The objective of this study is to identify the potential interactions between changes in the microbiota, changes in the immune status, the clinical evolution and the instability and progression of atherosclerosis.
Detailed description
The study will prospectively study two groups of patients : 1) patients with acute coronary syndrome and 2) age and sex matched patients with chronic stable documented atherosclerosis.
Immune cell populations and immune-related metabolites will be characterized, the genetic profile of the main known functional variants will be determined, and the oral, gastrointestinal, and blood microbiota will be compared in both groups in a transversal observational design.
In addition, 1-year clinical follow-up will be performed and correlation with the evolution of the microbiota and immune response in a longitudinal design will be conducted.
Besides, an angiographic substudy, for those patients included in the study but that require revascularization of culprit artery according to clinical indication, will be 1 year follow-up and functional assessment and intravascular imaging and the degree of remodelling of the atherosclerotic plaque will be correlated with the evolution of the microbiota and immune response in a longitudinal design.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome | – | Genetic: Gene variants in atherosclerosis, Other: Microbiota analysis, Other: Immunological analysis, Other: Clinical evaluationPatients with an episode of acute coronary syndrome. Clinical evaluation 1 year. Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis. |
| ACS-Angiographic substudy | – | Procedure: Assessment of the atherosclerotic plaque in a moderate lession., Genetic: Gene variants in atherosclerosis, Other: Microbiota analysis, Other: Immunological analysis, Other: Clinical evaluationPatients included in the Acute Coronary Syndrome group with clinical indication for revascularization. Clinical evaluation. Assessment of the atherosclerotic plaque in a moderate lession at baseline and 1-year . Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis |
| Chronic coronary atherosclerosis | – | Genetic: Gene variants in atherosclerosis, Other: Microbiota analysis, Other: Immunological analysis, Other: Clinical evaluationPatients with chronic atherosclerosis. Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Acute coronary syndrome candidates for the study will be all patients with an episode of acute coronary syndrome wwho enter the Gregorio Marañón General University Hospital who meet all of the inclusion criteria and none of the exclusion criteria. Chronic atherosclerosis candidates for the study will be all patients with chronic atherosclerosis under follow-up in the General University Hospital Gregorio Marañón that meet all the following inclusion criteria and none of the exclusion criteria.
Key inclusion criteria (5 listed)
- Diagnosis of acute coronary syndrome
- Signature of informed consent for the study (Annex I).
- Angiographic diagnosis, using catheterization or computed tomography of coronary atherosclerotic disease.
- Clinical situation of stable chronic ischemic heart disease.
- Signature of informed consent for the study (Annex III).
Key exclusion criteria (17 listed)
- Previous Ejection fraction of VI less than 30%.
- History of heart failure
- Systemic inflammatory diseases
- In treatment with corticosteroids or immunomodulators
- In treatment with antibiotics during the last month
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 |
|---|---|---|
| Assessment of the atherosclerotic plaque in a moderate lession.Also: Coronary blood collectionIn patients who have been successfully revascularized the artery responsible for AMI and also present an intermediate lesion (40-80%) in another coronary territory, the clinical care protocol of the Cardiology Service stipulates the need for a physiological assessment with guidance of pressure (FFR). The thickness of the fibrous cap shall be measured using optical coherence tomography. In addition to the FFR measurement, a complete physiological assessment with a Doppler-pressure guide. This will allow the procedure to be performed without additional risk to the patient. The physiological study will include the analysis of endothelium-dependent vascular function and endothelium-independent vascular function. | Procedure or surgery | ACS-Angiographic substudy |
| Gene variants in atherosclerosisFrom the blood samples of the patients, the total DNA will be extracted and the main functional variants identified in the literature will be genotyped | Genetic | ACS-Angiographic substudy, Acute Coronary Syndrome, Chronic coronary atherosclerosis |
| Microbiota analysisFrom the samples of blood, feces, oral cavity and blood, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons. | Other | ACS-Angiographic substudy, Acute Coronary Syndrome, Chronic coronary atherosclerosis |
| Immunological analysisA study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry | Other | ACS-Angiographic substudy, Acute Coronary Syndrome, Chronic coronary atherosclerosis |
| Clinical evaluationClinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration | Other | ACS-Angiographic substudy, Acute Coronary Syndrome, Chronic coronary atherosclerosis |
Primary outcome
Change from baseline in clinical evaluation at 12 months
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Cardiac events register including hemostasis and biochemical determinations
Change from baseline in fibrous cap thickness at 12 months
Time frame: Inclusion and 12 months
Angiographic substudy-Change from baseline in the thickness of the fibrous cap (μm) of an atherosclerotic plaque in the nonculprit vessel as measured using optical coherence tomography
9 secondary outcomes
Endothelial dysfunction
Time frame: Inclusion and 12 months
Intestinal microbiota composition changes 16S
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Intestinal microbiota composition changes metagenome
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Blood microbiota composition changes 16S
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Blood microbiota composition changes metagenome
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Oral microbiota composition changes 16S
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Oral microbiota composition changes metagenome
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Adaptive immune system status changes
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months
Innate immune system status changes
Time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 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 5 Aug 2021.
- Derived from this study: PubMed 38912228I Fernandez-Avila A, Gutierrez-Ibanes E, Martin de Miguel I, Sanz-Ruiz R, Gabaldon A, Fernandez-Aviles F, Gomez-Lara J, Fernandez-Castillo M, Vazquez-Cuesta S, Martinez-Legazpi P, Lozano-Garcia N, Blazquez-Lopez E, Yotti R, Lopez-Cade I, Reigadas E, Munoz P, Elizaga J, Correa R, Bermejo J. One-year longitudinal changes of peripheral CD4+ T-lymphocyte counts, gut microbiome, and plaque vulnerability after an acute coronary syndrome. Int J Cardiol Heart Vasc. 2024 Jun 4;53:101438. doi: 10.1016/j.ijcha.2024.101438. eCollection 2024 Aug.
- Individual participant dataSharing planned: Undecided
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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.
Francisco Fernández-Aviles, Prof, MD study director
Hospital General Universitario Gregorio Marañon
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 Acute Coronary Syndrome and Atherosclerosis, run by Hospital General Universitario Gregorio Marañon at 1 site in Spain.
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 17 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 5 Aug 2021. 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 Spain. 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?
Change from baseline in clinical evaluation at 12 months (time frame: Inclusion, 1 week, 1 month, 3 months, 6 months and 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 NCT03434483, 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 5 Aug 2021.