Scintigraphic Evaluation of Contractile and Coronary Reserve in Patients With Ischemic Cardiomyopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Number of patients with an ongoing LV remodeling and reverse LV remodeling.
研究概览
简要总结
According to single-photon emission computed tomography, the left ventricular contractile and coronary flow reserve (CFR) will be assessed in patients with ischemic cardiomyopathy. According to these data, the criteria for predicting the effectiveness of complex surgical treatment of this pathology will be evaluated.
详细描述
Before surgical intervention, all patients pass routine clinical analyzes undergo coronary angiography and 2D echocardiography. Some of patients in the ICM-1 and ICM-2 groups undergo stress echocardiography with dobutamine.
Coronary arteriography is performed using the Axiom Artis (Siemens; Erlangen, Germany) and transthoracic two-dimensional Doppler echocardiography (TTE) with the Acuson Sequoia 512 (Siemens; Erlangen, Germany)).
Besides, all of the ICM-1 and ICM-2 groups patients undergo myocardial perfusion imaging. Standard two-day stress-rest imaging protocol is used. Adenosine at a dosage of 140 mcg/kg/min (for 4 min) is used as a pharmaceutical stress agent.
ICM-1 group and Control group for GBPS undergo gated blood pool SPECT (GBPS) at rest and during increasing doses of dobutamine (5/10/15 μg/kg/min) (n = 60) ICM-2 group and Control group for CFR undergo dynamic SPECT (n = 40). This investigation is combined with routine myocardial perfusion imaging so patients are not exposed to extra stress.
Than ICM patients undergo surgical treatment of ICM in different volume. All of them receive coronary bypass grafting (CABG); some patients undergo the left ventricular reconstruction and intervention on the mitral valve.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •А) For ICM group:
- •History of myocardial infarction (MI) or revascularization (CABG or PCI);
- •> 75% stenosis of left main or proximal LAD and/ or stenosis of > 75% of ≥2 epicardial vessels (based on coronary angiography (CA) data);
- •LV EF <40% and increase in LV volumes according to echocardiography (ECHO)
- •B) For GBPS Control group
- •Absence of obstructive coronary artery lesion;
- •Absence of history of MI and revascularization.
- •C) For CFR Control group
- •Presence of obstructive coronary artery lesion;
- •Indications for coronary artery bypass grafting;
排除标准
- •(for all groups):
- •Presence of contraindications to the stress test with inotropic stimulation;
- •Inflammatory myocardial diseases;
- •The presence of severe hematological, neurological disorders, other psychosomatic conditions that impede research;
- •Life expectancy of less than 6 months (acute renal and hepatic failure, mental illness, malignant neoplasms of the final stages, unsuitable correction of brain injury).
结局指标
主要结局
Number of patients with an ongoing LV remodeling and reverse LV remodeling.
时间窗: 12 month
Ongoing LV remodeling is meant increase of LV end-systolic volume (LVESV) or decrease of LVESV≤10% according to 2D echocardiography in comparison to early postoperative period study. Reverse LV remodeling is meant decrease in LVESV \>10% according to 2D echocardiography in comparison to early postoperative period study.
次要结局
未报告次要终点