跳至主要内容
临床试验/NCT04542460
NCT04542460进行中(未招募)不适用

Chronic Total Coronary Occlusion; Arrhythmia in Patients With Adjunction of PCI to Optimal Medical Treatment Versus Optimal Medical Treatment and in Patients With Failed PCI.

Leif Thuesen1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
1
主要终点
Rate of clinically significant arrhythmias

研究概览

简要总结

In patients with a chronic total coronary occlusion (CTO ), clinically significant arrhythmia seems to be an important and a poorly investigated problem. The arrhythmia prevalence in an all-comer CTO-population is unknown, but in ICD-populations with ischemic heart disease, a CTO may be found in half of patients with life-threatening arrhythmia.The purpose of the CTO-ARRHYTHMIA study, is to investigate the incidence of clinically significant arrhythmias in CTO patients using an implantable loop recorder. Further, the investigators intend to identify predictors for arrhythmias as well as the impact on arrhythmia of optimized pharmacological treatment and revascularization in CTO patients.

详细描述

In angiographic materials, chronic total coronary occlusion (CTO) is present in approximately 15-25% of patients and in 25-50% of those with significant coronary disease. Until recently, because of low procedural success and increased risk of complications, PCI was a problematic treatment in these patients. The introduction of drug eluting stents and a variety of dedicated CTO devices combined with the evolution of specific CTO techniques have made revascularization by PCI a promising treatment.

In CTO patients, clinically significant arrhythmia seems to be an important and a poorly investigated problem. The arrhythmia prevalence in an all-comer CTO-population is unknown, but in ICD-populations with ischemic heart disease, a CTO may be found in half of patients with life-threatening arrhythmia. Further, in patients with ischemic heart disease receiving ICDs as primary prevention, presence of a CTO was an independent predictor of occurrence of ventricular arrhythmias, and in survivors of out-of-hospital cardiac arrest, the risk of ventricular arrhythmias was found to be increased in patients with a chronic total coronary occlusion. Nevertheless, the genesis of arrhythmia in CTO-patients is likely to be multifactorial. It has been documented, that ischemic heart disease patients who present with a chronic occlusion of at least one coronary artery are older and have additional risk factors such as hypertension, diabetes, lower left ventricular ejection fraction (LVEF) and more frequent myocardial infarction, i.e. a higher Chads2Vasc score (risk score for stroke in atrial fibrillation patients). Although LVEF is lower in patients with a chronic coronary occlusion, less than 1/3 are potential ICD candidates with an LVEF <35%. However, a recent study in consecutive post-AMI survivors documented the highest incidence of sudden cardiac death in patients with a relatively preserved LVEF.

The purpose of the CTO-ARRHYTHMIA study, is to investigate the incidence of clinically significant arrhythmias in CTO patients using an implantable loop recorder. Further, the investogators intend to identify predictors for arrhythmias as well as the impact on arrhythmia of optimized pharmacological treatment and revascularization in CTO patients. Here, CTO patients with failed PCI may be individuals with a particularly high risk of severe arrhythmias.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥1 CTO lesion amenable to PCI.
  • Stable or stabilized coronary artery disease.
  • Angiographic/echocardiographic signs of reversible perfusion.
  • CTO lesion in a coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm).

排除标准

  • Expected survival <1 year.
  • Patients with an indication of ICD due to EF < 35 or previous ventricular tachycardia.
  • Patients with a cardiac device i.e. ICD, pacemaker or cardiac resynchronizing treatment device.
  • Renal failure on dialysis.
  • Lesions treated with PCI within one month.
  • Indication for coronary artery bypass grafting (CABG). I.e. Two-or three vessel disease or left main disease and a syntax score >
  • Significant valvular heart disease.
  • Declined informed consent.
  • Regarding CMRI: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants.

结局指标

主要结局

Rate of clinically significant arrhythmias

时间窗: 1 year

Rate og clinically significant arrhythmias in PCI versus medically only treated patients by loop recorder (table 1) and in patients with failed PCI.

次要结局

未报告次要终点

研究者

发起方
Leif Thuesen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Leif Thuesen

Head of PCI Research

Aalborg University Hospital

研究点 (1)

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