Acute Coronary Syndromes (ACS)
Conditions
Keywords
intestinal permeability, unstable coronary artery disease, acute myocardial infarction, metabolomic, essential oils, dietary supplement, dysbiosis
Brief summary
The prospective experimental study aims to take an instantaneous photograph of the subject at time T0 and after 24 hours of intestinal permeability and dysbiosis indices in patients with acute coronary syndromes (ACS) which include unstable coronary artery disease (unstable angina) and acute myocardial infarction (AMI). The aim is to verify whether essential oils in particular formulations with high bioavailability are able to re-establish intestinal eubiosis after 2 months, confirmed by tests laboratory specifics such as metabolomics.
Detailed description
The subject arrives at the experimental center at time T0 to proceed with the hospital admission as scheduled. At time T0, during the visit, information regarding demographics, BMI, height, weight, etc... is collected. The subject will be subjected to a screening questionnaire, useful for collecting general information. After the visit with the medical examiner, three first-micturition urine samples, a serum sample, and a complete blood count test tube will be collected and blood tests will be performed, as per clinical practice. The subject will then be admitted to the experimental center. After 6 hours from the T0 visit, a second urine collection will be performed as per clinical practice (two samples per subject). After 12 hours from the T0 visit, a third urine collection will be performed as per clinical practice (two samples per subject) After 24 hours from the T0 visit, a fourth urine collection will be collected as per clinical practice (two samples per subject). At the end of the two months of drug and non-pharmacology therapy, patients will have to return to the experimental center for the second phase of the study. In this second phase, only first-micturition urine will be collected, which will serve to complete the metabolomics and intestinal dysbiosis data. Finally, all objective adverse events reported or reported by patients during pharmacological and non-pharmacological treatment will be recorded, particularly those that led to treatment discontinuation.
Interventions
DIETARY_SUPPLEMENTTea tree (Melaleuca alternifolia), Cinnamon (Cynnamomum zeylanicum) bark, Clove carnation (Eugenia caryopyllus) flowers, Red thyme (Thymus vulgaris) plant
Patients will take 2 capsules/day of the product
Sponsors
Casa di Cura Dott. Pederzoli
Herboplanet Srl
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
to each individual subject will be associated, in addition to conventional therapy, a non-pharmacological therapy consisting of essential oils and post and prebiotic component
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Signing of informed consent * 2\. Diagnosis of Acute Coronary Syndrome (ACS) * 3\. Age 30-70
Exclusion criteria
1. Use in the three months preceding the signing of the informed consent of: i) Lipid-lowering drugs containing statins, ezetimibe, fibrates ii) Lipid-lowering nutraceuticals containing monacolin K iii) Monoclonal antibodies that inhibit PCSK9 (proprotein convertase subtilisin/kexin type 9) such as Evolocumab and Alirocumab 2. Diagnosis of conditions such as HIV, cancer and diabetes I and II Furthermore, if a female patient becomes pregnant during the trial, this will be one of the reasons for early exit from the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| characterization of urinary metabolites | through study completion, an average of 1 year | to assess the presence of dysmetabolisms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| state of metabolic cardio risk | through study completion, an average of 1 year | picture of all the pro-atherogenic factors |
| urinary dysmetabolism | through study completion, an average of 1 year | interaction of non-pharmacological therapy and urinary dysmetabolisms |
Countries
Italy
Outcome results
None listed