Идёт набор NCT06209723

Vegetarian Diet and Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)

Без фазы С лечением Myocardial Infarction

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Vegetarian diet.
Кому может быть актуально: Состояния в реестре: Myocardial Infarction. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Нидерланды
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Effect of a Vegetarian Diet on Innate Immunity in Patients With Myocardial Infarction and in Healthy Volunteers (FRESH-MI Study)

Обзор

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 willingness to adapt a more vegetarian eating habit. Study subjects will follow a vegetarian diet for five weeks, whereafter a stabilisation period of six weeks will follow. Then, participants will follow to the other dietary intervention for five weeks. Blood will be drawn at given time points to analyse inflammatory parameters.

Подробное описание

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 partners / spouses will be randomly assigned to an immediate vegetarian diet or their habitual diet. Patients with AMI will be stratified for non-ST-elevation myocardial infarction (NSTEMI) or ST-elevation myocardial infarction (STEMI). The dietary intervention will start one week after the index event and will comprise a period of five weeks. After a stabilisation phase (six weeks), to assure normalisation of the inflammatory response secondary to the acute myocardial infarction, patients and their spouses will follow the other dietary intervention arm. Then, half of them will start directly with the other dietary intervention and half of them will start after a period of five weeks. Blood samples will be taken at the time points. Also, all participants will be asked to complete a questionnaire at baseline, after twelve weeks and at nine months follow-up. Infarct size as assessed by Cardiovascular Magnetic Resonance (CMR) imaging will be used to adjust cytokine levels.

Вмешательства

Другое Vegetarian diet
Participants will follow a vegetarian diet during a period of five weeks

Первичные конечные точки

The difference in cytokine production capacity (including TNF-α, IL-6, IL-10, IL-1β) of isolated peripheral blood mononuclear cells (PBMCs) after ex-vivo stimulation before and after the vegetarian diet compared to the habitual diet in patients with AMI [Срок оценки: five weeks]

Вторичные конечные точки (2)

The cytokine production capacity (including TNF-α, IL-6, IL-10, IL-1β) of isolated peripheral blood mononuclear cells after ex-vivo stimulation before and after following a vegetarian diet in participants without cardiovascular history. [Срок оценки: five weeks]
The frequency of the consumption of vegetables per week at nine months follow-up will be compared between patients with a recent acute myocardial infarction, who directly start with a vegetarian diet compared to a deferred start. [Срок оценки: 9 months]

Критерии участия

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

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

Здоровые добровольцы: Да