Assessment of the Effects of SGLT2 Inhibitors on Pericoronary Fat in Non-diabetic ACS Patients Without Heart Failure Using CCTA
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
研究概览
简要总结
The goal of this clinical trial is to learn if dapagliflozin, a sodium-glucose cotransporter 2 inhibitor (SGLT2i), can reduce coronary artery inflammation in people with acute coronary syndrome (ACS) who do not have diabetes or heart failure.
Coronary inflammation will be measured using the fat attenuation index (FAI), a marker derived from coronary CT angiography (CCTA) that quantifies inflammation in the fat tissue surrounding heart arteries.
The main questions it aims to answer are:
- Does dapagliflozin lower coronary artery inflammation as measured by FAI?
- Does dapagliflozin slow the progression of coronary plaques?
Researchers will compare participants who take dapagliflozin 10 mg daily plus standard therapy to those who receive standard therapy alone for 6 months.
Participants will:
- Undergo percutaneous coronary intervention (PCI) for ACS
- Have a baseline CCTA scan at 1 month after PCI, at which point they will be randomly assigned to receive dapagliflozin or standard care alone
- Have a follow-up CCTA scan at 6 months after randomization
- Have blood tests at the time of PCI, at randomization, and at 6 months after randomization
- Receive follow-up phone calls at 3 and 6 months after randomization
详细描述
SCIENTIFIC BACKGROUND
Residual inflammatory risk (RIR) has emerged as a major driver of adverse cardiovascular outcomes in patients with acute coronary syndrome (ACS), even after guideline-directed medical therapy and successful revascularization. Recent pooled analyses of the PROMINENT, REDUCE-IT, and STRENGTH trials demonstrated that high-sensitivity C-reactive protein (hsCRP), a marker of RIR, predicts future cardiovascular events more strongly than LDL-cholesterol in statin-treated patients.
Pericoronary adipose tissue (PCAT) fat attenuation index (FAI), measured by coronary CT angiography (CCTA), has been validated as a novel imaging biomarker that directly quantifies coronary artery inflammation. When coronary inflammation occurs, PCAT undergoes characteristic morphological changes with decreased lipid content and increased water-to-fat ratio, resulting in higher CT attenuation values (shifting from approximately -190 Hounsfield Units toward -30 HU). The CRISP-CT study validated this imaging biomarker and demonstrated its prognostic value for cardiac mortality independent of conventional cardiovascular risk factors.
SGLT2 inhibitors have established cardiovascular benefits in patients with diabetes or heart failure. Beyond glucose-lowering and diuretic effects, anti-inflammatory mechanisms may contribute to these benefits, including suppression of inflammatory cytokines such as interleukin-6 and monocyte chemoattractant protein-1, reduction of oxidative stress, and improvement of endothelial function. Clinical studies have shown that SGLT2 inhibitors reduce epicardial adipose tissue volume and may stabilize coronary plaques in diabetic patients. The EMPA-TROPISM study provided evidence that empagliflozin reduces epicardial adipose tissue volume even in non-diabetic patients with heart failure, suggesting glucose-independent mechanisms.
KNOWLEDGE GAP
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Diagnosis of acute coronary syndrome (including ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or unstable angina)
- •Undergoing percutaneous coronary intervention (PCI)
- •Presence of multivessel coronary artery disease with at least one non-culprit vessel not undergoing revascularization (for CCTA follow-up assessment)
- •Willing and able to provide written informed consent
排除标准
- •Prior or current diagnosis of diabetes mellitus
- •Prior or current diagnosis of chronic heart failure
- •Treatment with any SGLT2 inhibitor within 4 weeks prior to enrollment
- •Severe hepatic impairment
- •History of recurrent urogenital infections
- •Known allergy or intolerance to SGLT2 inhibitors
- •Pregnancy or breastfeeding
- •Systolic blood pressure <90 mmHg and/or diastolic blood pressure <60 mmHg
- •Severe chronic kidney disease (eGFR <30 mL/min/1.73 m²)
- •Current participation in another interventional clinical trial
- •Any other condition that, in the opinion of the investigator, would make the participant unsuitable for enrollment
研究者
Han Yaling
Prof.
Shenyang Northern Hospital