Investigation of the effect of trehalose on troponin and CRP levels in patients with ST elevation myocardial infarction (STEMI)

Investigation of the effect of trehalose on troponin and CRP levels in patients with ST elevation myocardial infarction (STEMI)

Triple-blind parallel randomized clinical trial with control group, on 100 patients

Patients with ST-elevation myocardial infarction (STEMI) who refers to cath lab of Ghaem Hospital, Mashhad, and met the inclusion criteria, will be enrolled to this study after informed consent. They will be divided randomly into two groups of intervention (trehalose) and control (placebo) and consume the administered trehalose/placebo for 2 months. The mentioned outcomes will be assessed and compared between two groups at different time points (as mentioned).

Inclusion Criteria: Patients with STEMI who refer to cath lab of Ghaem Hospital, Only one artery needs revascularization after angiography (and no need for more revascularization in the next 2 months), Satisfaction for participation in research project. Exclusion Criteria: Cardiogenic Shock

Intervention group: Trehalose 30 g before PCI, 30 g in the first 24 hours after PCI. Then 10 g per day for 2 months, made by Shaanxi Fruiterco Biotechnology Co.,Ltd. Placebo group: Placebo (containing erythritol) 30 g before PCI, 30 g in the first 24hours after PCI. Then 10 g per day for 2 months.

Primary Outcomes: High sensitive troponin (hs-Troponin) and high sensitive CRP (hs-CRP) (Before PCI, then 1 and 2 days after PCI (2 times in the first 48 hours after PCI)). Secondary Outcomes: Neutrophil to lymphocyte ratio (NLR) and Creatinine (Before PCI, then 1 and 2 days after PCI), Ejection Fraction (EF) by echocardiography (before PCI, before discharge, after 2 months), ECG changes (baseline, after performing PCI, 24 hours after PCI, after 2 months).

Block randomization will be done using the block sizes of 2 and 4 with randomization websites such as sealedenvelope.com. After randomization, the type of treatment will be written with odds and even numbers (or A/B codes) in separate papers and placed in an opaque envelope or the paper will be wrapped so that no one can see inside the paper (allocation concealment). After obtaining informed consent from the participants, one paper will be taken in order and according to the noted code, the participants will be placed in one of the intervention or placebo groups.

َAfter randomization, the patients will be placed in two groups of A/B (or odds/even codes) and will received the products similar in shape and color (blinding of participants). The physician who will give the products to participants, received the boxes of the products with randomized codes (so the physician is blind too). The information of the patients and theirs treatment groups will be written with randomized codes (A/B) (blinding of the assessor). Data will be entered to the SPSS software with codes (blinding of the analyzer).