The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15,630
- 试验地点
- 1
- 主要终点
- Stent Thrombosis
研究概览
简要总结
In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.
详细描述
A retrospective database of the hemodynamics department of the Centre Cardiologique du Nord and Clinica Mediterranea, comprising 15,630 consecutive angioplasties performed in unselected patients between February 1, 2008, and July 7, 2018, was used to identify complex angioplasties and standard angioplasties. Two categories of complex angioplasty were identified: complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria. These complex angioplasties were then compared with standard angioplasty (angioplasty with no complexity criteria).
The following criteria were employed to delineate complex or very complex angioplasties:
- Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI)
- Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI)
- Angioplasty of Chronic Coronary Occlusion (CCO-PCI)
- Angioplasty of a Bifurcation Lesion (CBL-PCI)
The following definitions pertain to the classification of angioplasty procedures:
- Standard angioplasty: This encompasses angioplasty procedures that do not meet the criteria for complexity.
- Complex angioplasty: This designation is applied to angioplasty procedures that meet at least one criterion for complexity.
- Very complex angioplasty: This designation is applied to angioplasty procedures that meet at least two criteria for complexity.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.
排除标准
- 未提供
研究组 & 干预措施
Non Complex PCI
The objective of this study is to examine the efficacy of percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES) in patients diagnosed with ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI).
干预措施: Non Complex PCI (Device)
Complex PCI
This study focuses on patients diagnosed with either STEMI or NSTEMI who have undergone complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).The following criteria were used to distinguish between complex and very complex angioplasty cases:
The following procedures have been identified as complex or very complex:
- Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI)
- Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI)
- Angioplasty of Chronic Coronary Occlusion (CCO-PCI)
干预措施: Complex PCI (Device)
结局指标
主要结局
Stent Thrombosis
时间窗: 5 years
The primary end point of the study is the rate of stent thrombosis
Death
时间窗: 5 years
The primary end point of the study is the rate of death
Acute Kidney Injury
时间窗: 1 years
The primary end point of the study is the rate of acute kidney injury
Coronary Obstruction Requiring Intervention
时间窗: 5 years
The primary end point of the study is the rate of coronary obstruction requiring intervention
Increase in Tnl and Tnt Levels
时间窗: 1 year
The primary end point of the study is the rate in increase of Tnl and Tnt levels
Rehospitalization
时间窗: 5 years
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
Myocardial Infarction
时间窗: 5 years
The primary end point of the study is the rate of myocardial infarction
Death
时间窗: 30 days
The primary end point of the study is the rate of death
Death
时间窗: 1 year
The primary end point of the study is the rate of death
Myocardial Infarction
时间窗: 30 days
The primary end point of the study is the rate of myocardial infarction
Myocardial Infarction
时间窗: 1 year
The primary end point of the study is the rate of myocardial infarction
Stent Thrombosis
时间窗: 30 days
The primary end point of the study is the rate of stent thrombosis
Stent Thrombosis
时间窗: 1 year
The primary end point of the study is the rate of stent thrombosis
Acute Kidney Injury
时间窗: 30 days
The primary end point of the study is the rate of acute kidney injury
Coronary Obstruction Requiring Intervention
时间窗: 30 days
The primary end point of the study is the rate of coronary obstruction requiring intervention
Coronary Obstruction Requiring Intervention
时间窗: 1 year
The primary end point of the study is the rate of coronary obstruction requiring intervention
Increase in Tnl and Tnt Levels
时间窗: 30 days
The primary end point of the study is the rate in increase of Tnl and Tnt levels
Rehospitalization
时间窗: 30 days
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
Rehospitalization
时间窗: 1 year
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
次要结局
- Target Lesion Revascularization(5 years)
- Target Vessel Revascularization(5 years)
- Target Vessel Revascularization(1 year)
- Target Lesion Revascularization(1 year)
研究者
Francesco Nappi
Consultan
Centre Cardiologique du Nord