Dapagliflozin Effects on Coronary Calcium and Epicardial Fat Assessed by Cardiotomography
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Changes in the coronary calcium score quantified by Agatston's score using simple coronary tomography. Quantified in agatston units (AU)
研究概览
简要总结
Calcification of the coronary arteries is a direct sign of atherosclerotic disease of the coronary arteries and has been shown to be a strong predictor of the risk of cardiovascular diseases, including myocardial infarction and/or cardiac death, especially in patients with Diabetes Mellitus type 2. Therefore, there is great interest in pharmacotherapies that improve the rates of cardiovascular complications, and modify the outcomes of this group of patients.
Large randomized controlled trials with SGLT2 inhibitors in patients with DM2 have shown a clear reduction in cardiovascular events among individuals with atherosclerotic disease. Atherosclerosis imaging allows measurable assessments of disease progression and activity, revealing early signs of potential drug effects. Noninvasive methods are preferred for serial imaging in drug trials due to the potential risks associated with invasive procedures. The coronary artery calcium quantification using the Agatston score is the most widely used method
详细描述
It is now well recognized that Coronary Artery Disease (CAD) is part of the spectrum of cardiovascular diseases (CVDs) that have common underlying risk factors and may manifest as myocardial infarction, stroke or death.
CAD is a pathological process characterized by the accumulation of atherosclerotic plaque in the epicardial arteries, whether obstructive or non-obstructive; it can have long and stable periods, but it can also become unstable at any time.
It is unknown whether the high risk provided by the presence of obstructive coronary artery atherosclerotic disease is due to stenosis per se, or due to its correlation with the total burden of atherosclerotic plaque. Studies suggest that calcified atherosclerotic burden, not stenosis, is the main predictor of future events of cardiovascular disease (myocardial infarction and cerebrovascular disease) and death in patients with coronary artery disease.
Atherosclerosis imaging allows measurable assessments of disease progression and activity, revealing early signs of potential drug effects. Non-invasive methods are preferable for serial imaging in drug trials because of the potential risks associated with invasive procedures. High participant dropout rates are also observed when invasive methods are used.
Therefore, coronary artery calcium scanning offers a simple, non-invasive, rapid, and reliable method to quantify coronary calcium, which is pathognomonic for established atherosclerosis. It is a powerful screening tool for asymptomatic patients at low or intermediate risk of CVD, including those with diabetes mellitus, and can potentially improve adherence to lifestyle advice and medication.
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
The blinding will be double blind, since neither the patient, the responsible investigator, the radiologists and the one who will perform the statistical analysis will know to which group each patient was assigned.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients over 18 years of age
- •Who meet the criteria of the fourth definition of infarction with and without ST segment elevation
- •Known with diabetes mellitus 2 or newly diagnosed diabetes according to ADA criteria
排除标准
- •Patients diagnosed with Type 1 Diabetes Mellitus
- •Patients on chronic replacement therapy for renal function using peritoneal dialysis or hemodialysis or with GFR less than 30 ml / min / 1.73m2
- •Patients who have recently undergone immunosuppressive therapy
- •Patients with a history of recurrent urinary tract infection
- •Patients known to be allergic to SGLT-2 inhibitors
- •Patients presenting as sudden aborted death.
- •Patients who after percutaneous coronary intervention require orotracheal intubation or present a state of shock
研究组 & 干预措施
Dapagliflozin
Dapagliflozin 10 mg orally every 24 hours for 12 months
干预措施: Dapagliflozin 10Mg Tab (Drug)
Placebo
Placebo orally every 24 hours for 12 months
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in the coronary calcium score quantified by Agatston's score using simple coronary tomography. Quantified in agatston units (AU)
时间窗: A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.
Standardized categories have been developed for the calcium score with scores of 0 indicating the absence of calcified plaque, 1 to 10 minimal plaque, 11 to 100 mild plaque, 101 to 400 moderate plaque, and \> 400 severe plaque. This is evaluated by the Agatston score. cardiac tomography will be performed on admission prior to hospital discharge and after 12 months of treatment in both groups.
changes in cardiac epicardial fat volume quantified in cm3 and evaluated by simple cardiac tomography.
时间窗: A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.
Visceral fat depot of the heart and can secrete bioactive molecules that have modulatory effects on the myocardium. Cardiac tomography will be performed on admission prior to hospital discharge and after 12 months of treatment in both groups.
次要结局
- Number of patients with new event of unstable angina(12 months)
- Number of patients with new event of acute myocardial infarction(12 months)
- Number of patients with progression of atherosclerotic disease. The increase in coronary calcium and the increase in epicardial fat after 12 months of treatment will be considered as progression.(A baseline tomography will be performed at the time of randomization and at 12 months of follow-up.)
- Mortality due to cardiovascular causes(12 months)
研究者
Hilda Elizabeth Macías Cervantes
principal investigator
Instituto Mexicano del Seguro Social