Status:
RECRUITING
Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)
Lead Sponsor:
Radboud University Medical Center
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to assess the effect of a vegetarian diet on innate immunity of patients with a recent acute myocardial infarction and healthy participants. Also, we will assess the...
Detailed Description
We will perform a proof-of-concept study according to a prospective randomized open label blinded endpoint (PROBE) design. Patients with an acute myocardial infarction (AMI) and their healthy life par...
Eligibility Criteria
Inclusion
- Inclusion Criteria for patients:
- Acute myocardial infarction (STEMI/NSTEMI) with a clear culprit lesion on angiography and successful primary percutaneous coronary intervention (PCI) \<1 week before randomisation
- Body mass index between 18.5 and 35 kg/m2
- Written informed consent
- Inclusion Criteria for healthy volunteers (life partners / souses)
- Body mass index between 18.5 and 35 kg/m2
- Written informed consent
- Exclusion Criteria for patients and healthy volunteers:
- Already on a vegetarian or vegan diet
- Previous myocardial infarction
- Diabetes Mellitus
- Medical history of any disease associated with immune deficiency (either congenital or acquired, including chemotherapy, chronic steroid use, organ transplant)
- Use of immunomodulatory drugs
- Vaccination less than one month before start of intervention
- Clinically significant infections within 1 months prior to start of intervention (defined as fever \>38.5 degrees Celsius)
- Active malignant haematological disease
- Known eating disorder (e.g., Anorexia nervosa, Bulimia nervosa)
- Exclusion Criteria for healthy volunteers
- \- Use of lipid lowering therapy
Exclusion
Key Trial Info
Start Date :
January 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06209723
Start Date
January 8 2024
End Date
September 1 2026
Last Update
January 17 2024
Active Locations (1)
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1
Radboudumc
Nijmegen, Netherlands