Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- The burden of myocardial fibrosis
研究概览
简要总结
Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis
详细描述
Severe symptomatic aortic stenosis is commonly encountered in clinical practice, affecting close to 5% of individuals older than 65 years of age, and carries a dismal prognosis if left untreated.(1,2) Chronically increased left ventricular afterload triggers a compensatory myocardial response, ultimately leading to ventricular hypertrophy, aimed at reducing chronically increased wall tension an restore cardiac performance.(3) Hypertrophy ultimately results in maladaptive changes and ultimately leads to heart failure and eventually increased risk of cardiac mortality. Myocardial fibrosis and altered myocardial perfusion appear to play a role in progressive cardiac decompensation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
Patients will be assigned a univocal identification code. Medical personnel in charge of baseline, in-hospital and follow-up data acquisition will be allowed to know each patient identity.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients referred to IRCCS Ospedale San Raffaele who are candidates to receive a TAVI implant for severe, symptomatic aortic stenosis under current appropriateness criteria and clinical practice guidelines will be considered eligible to take part in the study
排除标准
- •Age <18 years
- •Inability to express informed consent to take part in the present study.
- •Pregnancy or lactation
- •Pre-existing known disease determining a prognosis quo ad vitam shorter than the follow up of the present study
- •Significant chronic kidney disease (estimated glomerular filtration rate <30 ml/min)
- •Known significant epicardial coronary artery stenosis
- •Known contraindication to adenosine administration:
- •Known allergic reactions
- •Second or third degree atrioventricular block before the procedure (in absence of a functional permanent pacemaker)
- •Long QT syndrome
- •Unstable angina
- •Severe hypotension
- •Acutely decompensated heart failure
- •Chronic obstructive pulmonary disease with bronchospasm
- •Concomitant use of dypiridamole
研究组 & 干预措施
Coronary physiology evaluation
Patient will undergo TAVI and then Myocardial fibrosis will be evaluated on images acquired at the time of the cardiac CT obtained for TAVI planning. Briefly, an extra late post-contrast acquisition image will be acquired. The delayed post-contrast scan will be reconstructed with a soft convolution kernel and will be reformatted in the short- and long-axis planes (slice thickness 8 mm; gap 0 mm) in average mode.
干预措施: coronary physiology (Device)
结局指标
主要结局
The burden of myocardial fibrosis
时间窗: 1 year
Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume
Index of microcirculatory resistance (IMR)
时间窗: 1 year
IMR a validated estimate of resistance in the coronary capillary, computed as the ratio between transit time of a 3 cc bolus of room temperature saline and distal coronary artery pressure.
次要结局
- Acute change in coronary flow reserve (CRF)(1 year)
- Acute change in index of microcirculatory resistance (IMR)(1 year)
- Computed tomography derived extracellular volume(1 year)
- All-cause death(1 year)
- Cardiovascular death(1 year)
- Any rehospitalization(1 year)
- Cardiovascular rehospitalization(1 year)
- Acute change in coronary flow reserve (CRF)(1 year)
- Acute change in index of microcirculatory resistance (IMR)(1 year)
- Computed tomography derived extracellular volume(1 year)
- All-cause death(1 year)
- Cardiovascular death(1 year)
- Any rehospitalization(1 year)
- Cardiovascular rehospitalization(1 year)
研究者
Matteo Montorfano
Interventional cardiologist
IRCCS San Raffaele