Evaluation Through Innovative Examinations of Intestinal Dysbiosis Status in Patients Diagnosed With Cardiovascular Diseases and Evaluation of the Efficacy of Natural and Probiotic Extracts in the Non-pharmacological Approach to Improving Intestinal Dysbiosis Status.

Официальное название

Metabolomic and Cellular Inflammaging Investigation Study of Patients With Acute Coronary Syndrome (ACS)

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка Tea 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

Первичные конечные точки

• characterization of urinary metabolites [Срок оценки: through study completion, an average of 1 year]

Вторичные конечные точки (2)

• state of metabolic cardio risk [Срок оценки: through study completion, an average of 1 year]
• urinary dysmetabolism [Срок оценки: through study completion, an average of 1 year]

Критерии участия

Критерии включения

• 1\. Signing of informed consent
• 2\. Diagnosis of Acute Coronary Syndrome (ACS)
• 3\. Age 30-70

Критерии исключения

• 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

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• Ospedale P. Pederzoli Casa di Cura Privata S.p.A. — Peschiera del Garda

Идентификаторы

NCT: NCT07429227 · 748CET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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