Inflammation Reduction by TREhalose AdminisTration (IR-TREAT)

Mashhad University of Medical Sciences

Status and phase: Unknown; Phase 2

Conditions: Acute Coronary Syndrome

Treatments: Drug: Trehalose; Drug: Normal saline

Study type: Interventional

Funder types: Other

Identifiers

NCT03700424

964334

Details and patient eligibility

About

Arterial wall inflammation has been consistently suggested to serve a causal role in promoting atherosclerosis and predisposing to hard cardiovascular outcomes. Therefore, there is a global trend in the pharmaceutical industry to develop safe and effective anti-inflammatory agents that could lessen arterial wall inflammation and prevent its detrimental impact on atheroma growth and instability. To this end, autophagy has emerged as a key regulator of inflammation and dysfunctional autophagy machinery has been consistently reported as a contributing factor to atherosclerosis and inflammation. Trehalose, a natural disaccharide sugar found extensively among miscellaneous organisms, by preventing protein denaturation plays various protective roles against stress conditions. Numerous studies indicated trehalose's ability to induce macrophage autophagy-lysosomal biogenesis and reduce inflammation. Also, intravenous (IV) administration of trehalose showed beneficial effects in the reversal of atherosclerosis in atherosclerotic animals. Therefore, in this study, the investigators will explore the potential efficacy of IV trehalose administration on arterial inflammation by employing an positron emission tomography (PET) with 18F-labeled fluoro-2-deoxyglucose (18F-FDG) and computed tomography (18F-FDG PET/CT) technique which noninvasively characterizes vascular inflammation and atherosclerosis.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged between 18-55 years
• Having a history of acute coronary syndrome
• Having a baseline high-sensitivity C-reactive protein (hs-CRP) of ≥ 2mg/L
• Willingness to participate in the trials.

Exclusion criteria

• Lactation or breastfeeding
• Diabetes mellitus
• Nephrotic syndrome or Estimated Glomerular Filtration Rate (eGFR) < 30/mL/min/1.73m2
• Active or recurrent hepatic disease or/and alanine aminotransferase (ALT)/aspartate aminotransferase (AST) (ALT/AST) of > 3 times upper normal limit or total bilirubin of > 2 times upper normal limit
• Active infectious or febrile disease
• Any type of malignancy
• History of transplantation
• Consumption of immunosuppressive drugs.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15 participants in 2 patient groups, including a placebo group

Trehalose

Experimental group

Description:

Participants will be received intravenous trehalose infusion weekly (15 g/week) for a period of 12 weeks

Treatment:

Drug: Trehalose

Placebo

Placebo Comparator group

Description:

Participants will be received equal volume of normal saline weekly for a period of 12 weeks

Treatment:

Drug: Normal saline