Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Remote plaque volume
研究概览
简要总结
Subjects with urgently reperfused type I myocardial infarction (MI) will be recruited and randomized to receive either placebo or the oral inflammasome (NLRP3) inhibitor dapansutrile. The primarily outcome measure will be carotid plaque volume change over 6 months; secondary outcome measures will be plaque inflammatory activity and coronary microvascular function.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute type I myocardial infarction (NSTEMI or STEMI)
- •Reperfusion therapy planned or performed within prior 48 hrs
- •Carotid or femoral artery plaque at baseline, or carotid intima media thickness >1.5 mm
排除标准
- •Type II MI
- •Failed primary PCI or need for emergent bypass surgery
- •Severe heart failure (NYHA class IV)
- •Life-threatening complication of MI (myocardial rupture, ischemic VSD, papillary muscle rupture)
- •Refractory ventricular arrhythmias
- •Allergy to dapansutril, OLT177, or drugs in the same class
- •Co-morbidity limiting 6 month survival
- •Active malignancy or recent malignancy with any systemic anti-cancer treatment
- •Active infection
- •Use of immunosuppressive medications or immunodeficiency disorder
- •Neutropenia (ANC <2,000)
- •Moderate or severe renal impairment (GFR <30 ml/min)
- •Recent stroke (within previous 3 months)
- •Allergy to ultrasound enhancing agents or polyethylene glycol
- •Pregnancy or breastfeeding
研究组 & 干预措施
Dapansutrile
Subjects randomized to receive oral dapnsutrile
干预措施: Dapansutrile (Drug)
Control
Subjects randomized to receive oral placebo
干预措施: Placebo (Other)
结局指标
主要结局
Remote plaque volume
时间窗: 6 months
Carotid artery plaque volume change by ultrasound measured by 3D ultrasound. Outcome units will be cm3 averaged for bilateral carotid arteries.
次要结局
- Plaque inflammation(3 months)
- Coronary microvascular function(3 months)
研究者
Jonathan Lindner, MD
Professor of Medicine, Vice Chief for Research, Cardiovascular Division
University of Virginia