Investigating the Utility of Remote Index of Microvascular Resistance in Patients With Chronic Total Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Change in exercise time on Bruce protocol baseline
研究概览
简要总结
This is prospective cohort study in subjects with a planned percutaneous coronary intervention (PCI) of their chronic total occlusion (CTO). The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects meeting inclusion criteria with a coronary flow wire. Evaluation of coronary microvascular function may be performed using indirect methods, however the rationale behind the present study is to directly measure microvascular function using direct coronary flow measurements, since the subjects in the study are to undergo a clinically-indicated cardiac catheterization. The overall purpose of the study is to define the presence and severity of coronary microvascular dysfunction subjects with CTO. The study is designed to enroll 50 subjects with CTO in the span of 3 years. There will be a 6-month assessment of the outcomes of death and cardiovascular death. As the study includes FDA approved tests, there will be no safety endpoint per se, however there will be a mechanism for monitoring adverse events as will be described in detail.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age ≥ 21 years
- •seen at University of Chicago Medical center with a planned PCI of a single CTO vessel
- •must have either stable angina or angina equivalent
- •must have a CTO with a clear donor vessel supplying most of the collaterals.
排除标准
- •subjects with a pacemaker or implantable cardioverter defibrillator
- •contraindication to cardiac MRI, adenosine, heparin, or nitroglycerin
- •cardiac transplantation
- •Estimated glomerular filtration rate (eGFR) ≤ 30 mL/min/1.73m2, given the risk of contrast-induced nephropathy (CIN) and nephrogenic systemic fibrosis (NSF) associated with iodinated and gadolinium-based contrast agents, respectively, in patients with significant renal dysfunction
- •Women who may potentially be pregnant will receive a pregnancy test and be excluded if pregnant
- •Vulnerable populations such as children, college students, prisoners, non-English speakers, and those with diminished decision-making capacity
- •Inability or refusal to consent for the study.
研究组 & 干预措施
Subjects with Chronic Total Occlusion (CTO)
All subjects in this study have been scheduled for a clinically-indicated cardiac catheterization.
干预措施: Directly measure microvascular function using direct coronary flow measurements (Other)
结局指标
主要结局
Change in exercise time on Bruce protocol baseline
时间窗: 6 months
Change in exercise time from baseline to 6 months post-PCI will be measured. Scale is linear and measured in seconds (can be a negative number), with higher numbers indicating a favorable outcome.
Change in SAQ from baseline to 6 months
时间窗: 6 months
Change in Seattle Angina Questionnaire (SAQ) from baseline to 6 months post-PCI will be measured. Scale is linear and 0-100 units, with higher numbers indicating a favorable outcome.
IMR of opened CTO vessel
时间窗: 6 months
Following CTO PCI, IMR of the opened vessel will be measured. Scale is linear and 1-100 units, higher numbers being worse outcome. 3) Change in SAQ from baseline to 6 months
Baseline myocardial quality of the CTO-supplied vascular bed.
时间窗: Day of procedure
Characterize the microvascular resistance of the donor vessel to 50 CTOs as it relates to vascular bed quality of the CTO-supplied territory. Scaled from 0-102, with 102 being worse than 0. 1. Baseline myocardial quality
次要结局
未报告次要终点