The Use of Intravenous Trehalose to Reduce Vascular Inflammation in Acute Coronary Syndrome
试验速览
- 阶段
- 2 期
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Arterial wall inflammation in the aorta and carotid arteries
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study will be performed double-blind
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Trehalose
Participants will be received intravenous trehalose infusion weekly (15 g/week) for a period of 12 weeks
干预措施: Trehalose (Drug)
Placebo
Participants will be received equal volume of normal saline weekly for a period of 12 weeks
干预措施: Normal saline (Drug)
结局指标
主要结局
Arterial wall inflammation in the aorta and carotid arteries
时间窗: At the beginning and end of the intervention trial (Day 0 and week 12)
This will be assessed using the 18F-FDG PET/CT imaging technique
次要结局
- Measuring thyroid-stimulating hormone (TSH) to assess thyroid function (Safety)(At the beginning and end of the intervention trial (Day 0 and week 12))
- Assessing glucose (Safety)(At the beginning and end of the intervention trial (Day 0 and week 12))
- Measuring alanine aminotransferase (ALT), aspartate aminotransferase (AST) and bilirubin (Bil) to assess liver function (Safety)(At the beginning and end of the intervention trial (Day 0 and week 12))
- Measuring creatinine (Cr), urine (Ur) and blood urea nitrogen (BUN) to assess renal function (Safety)(At the beginning and end of the intervention trial (Day 0 and week 12))
- Evaluating electrocardiogram (ECG) and heart rhythm to assess heart function (Safety)(At the beginning and end of the intervention trial (Day 0 and week 12))
- Measuring creatinine phosphokinase (CPK) to detect muscle damage (Safety)(At the beginning and end of the intervention trial (Day 0 and week 12))
- Carotid intima-media thickness (cIMT)(At the beginning and end of the intervention trial (Day 0 and week 12))
- Measuring beclin-1 to assess autophagy activation(At the beginning and end of the intervention trial (Day 0 and week 12))
- Measuring high-sensitivity C-reactive protein (hs-CRP) to assess systemic inflammation(At the beginning and end of the intervention trial (Day 0 and week 12))
- Measuring complete blood count (CBC) (Safety)(At the beginning and end of the intervention trial (Day 0 and week 12))
- Assessing lipid profile (Safety)(At the beginning and end of the intervention trial (Day 0 and week 12))
研究者
Amirhossein Sahebkar
Assistant Professor at Mashhad University of Medical Sciences
Mashhad University of Medical Sciences