Status:
COMPLETED
Impact of MEditerranean Diet, Inflammation and Microbiome After an Acute Coronary Syndrome
Lead Sponsor:
Consorcio Centro de Investigación Biomédica en Red (CIBER)
Collaborating Sponsors:
Hospital General Universitario Gregorio Marañon
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
In the MEDIMACS project, the investigators will use a randomized clinical-trial design to address the effects of mediterranean diet on atherosclerotic plaque vulnerability and coronary endothelial fun...
Detailed Description
Coronary atherosclerosis is a leading cause of mortality and disability worldwide. Continuous efforts are needed to improve secondary prevention and understand the mechanism underlying disease progres...
Eligibility Criteria
Inclusion
- Adult patients undergoing cardiac catheterization for an acute coronary syndrome.
- At least 1 non-causal lesion in a coronary segment with a stenosis diameter between 40-70% that will not be submitted to intervention during the revascularization procedure.
- Disposition and possibility to modify the diet.
- With the ability to track and answer questionnaires.
- Signature of informed consent for the study
Exclusion
- TIMI score \<3 in the injury
- Reference lesion with diameter \<2.0 mm
- LV ejection fraction (EF) less than 45%.
- Active systemic infection
- Active periodontal disease
- Chronic inflammatory disease
- Active treatment with corticosteroids or immunomodulators
- Renal insufficiency with glomerular filtration less than 30 mL / min
- Severe hepatic insufficiency (liver cirrhosis in Child B or C stages).
- Comorbidity with life expectancy of less than one year
Key Trial Info
Start Date :
May 14 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2022
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03842319
Start Date
May 14 2019
End Date
August 2 2022
Last Update
October 3 2022
Active Locations (1)
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1
Hospital General Universitario Gregorio Marañón
Madrid, Spain, 28007