ISCHEMIA-LVD: International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 1,200
- 试验地点
- 6
- 主要终点
- Composite Cognitive Score
研究概览
简要总结
The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Left ventricular ejection fraction (LVEF) ≤ 40% within prior 6 months (any local measurement, made within the past 6 months using echocardiography, multigated acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography is acceptable, provided no subsequent measurement above 40%)
- •Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel disease including left anterior descending (LAD) artery disease) on coronary CT angiography (CCTA) or invasive coronary angiography
- •CAD amenable to either PCI or CABG as determined by the local heart team
- •Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
- •Participant is able and willing to give written informed consent
排除标准
- •Decompensated heart failure or cardiogenic shock in the past 48 hours prior to randomization
- •Concomitant significant valvular heart disease requiring surgery
- •Prior cardiac surgery
- •Dementia with loss of capacity to consent (clinically evident or previously diagnosed)
- •Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
- •History of noncompliance with medical therapy
- •Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
- •Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)
研究组 & 干预措施
CABG
Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive CABG.
干预措施: Coronary artery bypass grafting (CABG) (Procedure)
GDMT
Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive GDMT.
干预措施: Guideline-directed medical therapy (GDMT) (Procedure)
PCI
Participants with multivessel coronary artery disease (CAD) and heart failure with reduced ejection fraction (HFrEF) who are assigned to receive PCI.
干预措施: Percutaneous coronary intervention (PCI). (Procedure)
结局指标
主要结局
Composite Cognitive Score
时间窗: Month 12
A composite score of various cognitive measures. Note that the total score range, calculation and interpretation to be updated upon submission of study protocol/materials to NYU Grossman School of Medicine IRB.
Kansas City Cardiomyopathy Questionnaire (KCCQ) Score
时间窗: Month 12
The KCCQ is an 8-item assessment of heart failure (HF)-related health status. The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF
时间窗: Month 12
Composite calculation of the number participants who experience death, nonfatal MI, stroke, or hospitalization for HF in each arm.
次要结局
- Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause(Month 12)
- Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score(Month 12)
- Self-Care of Heart Failure Index (SCHFI)(Month 12)
- Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability(Month 12)
- Composite Number of: Death or Hospitalization for HF(Month 12)