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临床试验/NCT05464940
NCT05464940尚未招募不适用

Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial

Kansas City Heart Rhythm Research Foundation9 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
9
主要终点
Number of Participants With Atrial Fibrillation Induction

研究概览

简要总结

This "How caffeine Induces Atrial Tachyarrhythmias" trial will be a multi-center, randomized, double-blinded trial of intravenous caffeine versus placebo among patients undergoing pulmonary vein isolation procedures for Atrial Fibrillation(AF).

详细描述

The mechanism by which caffeine might change cardiac electrophysiologic properties is largely unknown. Most of the prior studies conducted have evaluated the correlation based on the premise of oral consumption. One caveat among such study designs can be underreporting or overreporting the amount of caffeine ingested. To this date, no clinical trials exist that has studied the in vivo effects of caffeine to assess the atrial refractory period and conduction velocity and its potential to cause atrial or ventricular ectopy or sustained arrythmia induction including Atrial Tachycardia(AT)/Atrial Fibrillation(AF)/Ventricular Tachycardia(VT)/Ventricular Fibrillation(VF). As it is hypothesized that decreasing the atrial refractory period can render atria more prone to fibrillation. The pulmonary veins have proven integral to AF pathophysiology, the relationship between pulmonary vein electrophysiology and lifestyle factors in particular has not previously been assessed. It is also not clear if caffeine increases the risk of AF on those patients with known AF diagnosis. To bridge this gap, a randomized controlled trial is proposed to assess the effects of intravenous caffeine on atrial activity during AF ablation procedures.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •All adult patients from 21-90 years of age with new onset Paroxysmal Atrial Fibrillation presenting in sinus rhythm or AF of recent onset (the latter confirmed by sinus rhythm documented no more than 1 week prior) undergoing AF ablation will be included in the study.

排除标准

  • •Patients will be excluded if any of the following were identified:
  • •History of substance abuse or alcoholism.
  • •Left ventricular ejection fraction <50%.
  • •Liver dysfunction.
  • •Inability to give informed consent.
  • •Amiodarone uses within 1 month prior to procedure.
  • •AAD use within 24 h prior to the procedure
  • •Severe intolerance to caffeine.

研究组 & 干预措施

Group assigned to receive caffeine

Active Comparator

干预措施: Intravenous caffeine (Other)

Group assigned to receive masked placebo

Placebo Comparator

干预措施: Masked Placebo (Other)

结局指标

主要结局

Number of Participants With Atrial Fibrillation Induction

时间窗: 1 day

Induction of Atrial fibrillation will be attempted by pacing and isoproterenol infusion following study drug infusion. The ability to induce atrial fibrillation (yes or no) will be recorded as the primary outcome.

次要结局

  • Number of patients with Changes in conduction time(1 day)
  • Number of patients with Site-specific changes in AERP(Atrial Effective Refractory Period)(1 day)
  • Number of patients with Induction of Atrial Fibrillation/Atrial Tachycardia (AF/AT) or other arrhythmias(1 day)
  • Number of patients with Identification of non-pulmonary triggers of AF(1 day)

研究者

发起方
Kansas City Heart Rhythm Research Foundation
申办方类型
Other
责任方
Sponsor

研究点 (9)

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