Clinical trial NCT03700424: Inflammation Reduction by TREhalose AdminisTration
Official title: The Use of Intravenous Trehalose to Reduce Vascular Inflammation in Acute Coronary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Acute Coronary Syndrome
Keywords: Acute Coronary Syndrome
Trehalose
Arterial inflammation
Autophagy
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2018-10-09
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Arterial wall inflammation in the aorta and carotid arteries
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
Secondary outcomes:
measure: Carotid intima-media thickness (cIMT)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Measuring beclin-1 to assess autophagy activation
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Measuring high-sensitivity C-reactive protein (hs-CRP) to assess systemic inflammation
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Measuring complete blood count (CBC) (Safety)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Assessing lipid profile (Safety)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Assessing glucose (Safety)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Measuring thyroid-stimulating hormone (TSH) to assess thyroid function (Safety)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Measuring alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin (Bil) to assess liver function (Safety)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Measuring creatinine (Cr), urine (Ur) and blood urea nitrogen (BUN) to assess renal function (Safety)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Evaluating electrocardiogram (ECG) and heart rhythm to assess heart function (Safety)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
measure: Measuring creatinine phosphokinase (CPK) to detect muscle damage (Safety)
timeFrame: At the beginning and end of the intervention trial (Day 0 and week 12)
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Ghaem Educational, Research and Treatment Center
state: Razavi Khorasan
Study officials:
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