NCT03434483

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
156

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 8, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

February 25, 2018

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 8, 2021

Completed
Last Updated

August 5, 2021

Status Verified

August 1, 2021

Enrollment Period

3 years

First QC Date

January 8, 2018

Last Update Submit

August 3, 2021

Conditions

Acute Coronary SyndromeAtherosclerosis

Keywords

MicrobiotaImmunityGeneticsAtherosclerosis

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in clinical evaluation at 12 months

    Cardiac events register including hemostasis and biochemical determinations

    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

    Inclusion and 12 months

Secondary Outcomes (9)

  • Endothelial dysfunction

    Inclusion and 12 months

  • Intestinal microbiota composition changes 16S

    Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months

  • Intestinal microbiota composition changes metagenome

    Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months

  • Blood microbiota composition changes 16S

    Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months

  • Blood microbiota composition changes metagenome

    Inclusion, 1 week, 1 month, 3 months, 6 months and 12 months

  • +4 more secondary outcomes

Study Arms (3)

Acute Coronary Syndrome

Patients with an episode of acute coronary syndrome. Clinical evaluation 1 year. Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis.

Genetic: Gene variants in atherosclerosisOther: Microbiota analysisOther: Immunological analysisOther: 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

Procedure: Assessment of the atherosclerotic plaque in a moderate lession.Genetic: Gene variants in atherosclerosisOther: Microbiota analysisOther: Immunological analysisOther: Clinical evaluation

Chronic coronary atherosclerosis

Patients with chronic atherosclerosis. Gene variants in atherosclerosis. Microbiota analysis. Immunological analysis.

Genetic: Gene variants in atherosclerosisOther: Microbiota analysisOther: Immunological analysisOther: Clinical evaluation

Interventions

Assessment of the atherosclerotic plaque in a moderate lession.PROCEDURE

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.

Also known as: Coronary blood collection
ACS-Angiographic substudy
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

ACS-Angiographic substudyAcute Coronary SyndromeChronic coronary atherosclerosis
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.

ACS-Angiographic substudyAcute Coronary SyndromeChronic coronary atherosclerosis
Immunological analysisOTHER

A study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry

ACS-Angiographic substudyAcute Coronary SyndromeChronic coronary atherosclerosis
Clinical evaluationOTHER

Clinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration

ACS-Angiographic substudyAcute Coronary SyndromeChronic coronary atherosclerosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • Diagnosis of acute coronary syndrome
  • Signature of informed consent for the study (Annex I).

You may not qualify if:

  • 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
  • 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).
  • Renal insufficiency with creatinine clearance less than 30 ml / h
  • Hepatic insufficiency: patients with cirrhosis in Child B or C stages will be excluded.
  • 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).
  • Previous Ejection fraction of VI less than 30%.
  • History of heart failure
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Related Publications (1)

  • 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.

    PMID: 38912228DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Feces, blood, salive

MeSH Terms

Conditions

Acute Coronary SyndromeAtherosclerosis

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesArteriosclerosisArterial Occlusive Diseases

Study Officials

  • Francisco Fernández-Aviles, Prof, MD

    Hospital General Universitario Gregorio Marañón

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD Cardiology Department HGUGM

Study Record Dates

First Submitted

January 8, 2018

First Posted

February 15, 2018

Study Start

February 25, 2018

Primary Completion

February 8, 2021

Study Completion

February 8, 2021

Last Updated

August 5, 2021

Record last verified: 2021-08

Locations

ES(1)