Status:
COMPLETED
The Microbiome as a Target for Precision Medicine in Atherosclerosis
Lead Sponsor:
Hospital General Universitario Gregorio Marañon
Collaborating Sponsors:
Fundación para la Investigación Biomédica del Hospital Gregorio Maranon
Conditions:
Acute Coronary Syndrome
Atherosclerosis
Eligibility:
All Genders
18+ years
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 th...
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 po...
Eligibility Criteria
Inclusion
- Inclusion Criteria Acute coronary syndrome group:
- Diagnosis of acute coronary syndrome
- Signature of informed consent for the study (Annex I).
- Exclusion Criteria Acute coronary syndrome group:
- 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:
- 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.
- Inclusion Criteria Chronic atherosclerosis group:
- 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).
- Exclusion Criteria Chronic atherosclerosis group:
- 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
Exclusion
Key Trial Info
Start Date :
February 25 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 8 2021
Estimated Enrollment :
156 Patients enrolled
Trial Details
Trial ID
NCT03434483
Start Date
February 25 2018
End Date
February 8 2021
Last Update
August 5 2021
Active Locations (1)
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1
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007