Impact of Rotational Atherectomy on Coronary Microvascular Function in Patients With Stable Angina and Calcified Coronary Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The incidence of coronary microvascular dysfunction
研究概览
简要总结
The purpose of this observational study is to compare the impact of rotational atherectomy to conventional stenting and to investigate how it may affect coronary microcirculation in patients with calcified coronary artery lesions and stable CAD.
The study's objectives are to:
- investigate the impact of rotational atherectomy on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction;
- investigate the impact of conventional stenting on the prevalence of post-percutaneuos coronary intervention coronay microvascular dysfunction; and
- compare the impact of both percutaneuos coronary interventions on coronary microvascular dysfunction.
Patients with calcified lesions will be enrolled prospectively and will have serial invasive and non-invasive microvascular testing prior to and after rotational atherectomy or conventional stenting.
详细描述
Rotational atherectomy (RA) is a medical procedure used to treat patients with severe atherosclerosis, a condition that causes plaque buildup within the artery walls, resulting in narrowing of the blood vessels and decreased blood flow to the heart. RA is a technique that involves breaking up and removing plaque from the artery with a small, high-speed rotating burr.
However, RA is not without risks. One of the major risks associated with RA is the potential damage to the artery wall and surrounding tissue. This can lead to complications such as bleeding, blood clots, or injury to the heart or other organs. Additionally, the high-speed rotation of the burr can generate heat, which may damage the artery wall or cause the release of harmful particles into the bloodstream.
Another hypothesized risk of RA is its impact on microcirculation, which refers to the smallest blood vessels in the body. RA can cause disruption to these vessels, leading to a decrease in blood flow and potentially causing damage to tissues and organs that depend on them.
The purpose of this study is to look into the effect of rotational atherectomy on coronary microcirculation.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient diagnosed with stable coronary artery calcified lesion requiring Percutaneous coronary intervention
排除标准
- •patients with a history of old myocardial infarction or history of coronary artery bypass grafting (CABG) or Percutaneous coronary intervention PCI
- •Patients with signs of chronic infection, prolong usage of corticosteroids or compromised immune system
- •patients had contraindication of adenosine triphosphate (ATP);
- •had a history of liver or renal function dysfunction
- •Patients with dementia
- •Patients being referred to CABG
- •unable to provide informed consent;
- •had pregnancy or life span < 1 year.
- •Presence of sever structural valvular heart disease
- •Presence of significant left main disease
- •Unability to measure the index of microcirculatory resistance due to (death or retraction from the study ...etc)
- •Inability to perform successful PCI
研究组 & 干预措施
Rotational Atherectomy
Patients who are scheduled to have rotational atherectomy will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the rotational atherectomy procedure.
干预措施: coronary pressure/temperature sensor-tipped guidewire (Diagnostic Test)
Rotational Atherectomy
Patients who are scheduled to have rotational atherectomy will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the rotational atherectomy procedure.
干预措施: Angiography-derived index of microcirculatory resistance (IMRangio) (Diagnostic Test)
Conventional Stenting
Patients who are scheduled to have conventional stenting will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the conventional stenting procedure.
干预措施: coronary pressure/temperature sensor-tipped guidewire (Diagnostic Test)
Conventional Stenting
Patients who are scheduled to have conventional stenting will be labeled in this group; patients in this group will have invasive and non-invasive microvascular testing before and after the conventional stenting procedure.
干预措施: Angiography-derived index of microcirculatory resistance (IMRangio) (Diagnostic Test)
结局指标
主要结局
The incidence of coronary microvascular dysfunction
时间窗: 1 day
Microcirculatory dysfunction will be defined as having an IMR value ≥ 25 U and a CFR value \< 2.5 U or angio IMR ≥ 25 U
次要结局
- Rate of Major adverse cardiovascular events(1 year)
- The incidence of coronary microvascular dysfunction(1 year)
- Seattle Angina Questionnaire score(1 year)
研究者
Ali Aldujeli
Cardiovascular disease consultant
Lithuanian University of Health Sciences