Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction

Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

• Другое Intravenous caffeine
  Group assigned to receive caffeine will receive intravenous(IV) caffeine and sodium benzoate infusion starting at 250-500 mg. This method will use an automated algorithm that adjusts the flow of the infusion depending on the individual's sex and weight and then in a serial fashion in response to blood caffeine measurements. Serial blood caffeine measurements at pre-determined intervals according to the algorithm will be until a steady state is obtained.
• Другое Masked Placebo
  The patients assigned to the masked placebo will receive 5% dextrose in 0.45% saline using the same infusion protocol for a random length of time that was within 1 standard deviation(SD) of the mean time to achieve a steady state using the caffeine protocol (17+4 min). To maintain blinding, caffeine blood concentration measurements that will be randomly generated within 2 SDs of the predicted values calculated by the algorithm will be used and verbally communicated for placebo infusions.

Первичные конечные точки

• Number of Participants With Atrial Fibrillation Induction [Срок оценки: 1 day]

Вторичные конечные точки (4)

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

Критерии участия

Критерии включения

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.

Критерии исключения

Patients will be excluded if any of the following were identified:

• History of substance abuse or alcoholism.
• Left ventricular ejection fraction <50%.
• Liver dysfunction.
• Pregnancy.
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Другое

Центры проведения

США · 9 центров

• Loma Linda University — Loma Linda
• Menorah Medical Center — Overland Park
• Kansas City Heart Rhythm Institute — Overland Park
• Overland Park Regional Medical Center — Overland Park
• Centerpoint Medical Center Clinic — Independence
• Centerpoint Medical Center — Independence
• Research Medical Center Clinic — Kansas City
• Research Medical Center — Kansas City
• … и ещё 1 центр

Публикации

• McCarthy DM, Mycyk MB, DesLauriers CA. Hospitalization for caffeine abuse is associated with abuse of other pharmaceutical products. Am J Emerg Med. 2008 Sep;26(7):799-802. doi: 10.1016/j.ajem.2007.10.018. PMID 18774047
• Chen Y, Parrish TB. Caffeine's effects on cerebrovascular reactivity and coupling between cerebral blood flow and oxygen metabolism. Neuroimage. 2009 Feb 1;44(3):647-52. doi: 10.1016/j.neuroimage.2008.09.057. Epub 2008 Oct 19. PMID 19000770
• Temple JL. Caffeine use in children: what we know, what we have left to learn, and why we should worry. Neurosci Biobehav Rev. 2009 Jun;33(6):793-806. doi: 10.1016/j.neubiorev.2009.01.001. Epub 2009 Jan 20. PMID 19428492
• Reissig CJ, Strain EC, Griffiths RR. Caffeinated energy drinks--a growing problem. Drug Alcohol Depend. 2009 Jan 1;99(1-3):1-10. doi: 10.1016/j.drugalcdep.2008.08.001. Epub 2008 Sep 21. PMID 18809264
• Wendt IR, Stephenson DG. Effects of caffeine on Ca-activated force production in skinned cardiac and skeletal muscle fibres of the rat. Pflugers Arch. 1983 Aug;398(3):210-6. doi: 10.1007/BF00657153. PMID 6634380
• Rashid A, Hines M, Scherlag BJ, Yamanashi WS, Lovallo W. The effects of caffeine on the inducibility of atrial fibrillation. J Electrocardiol. 2006 Oct;39(4):421-5. doi: 10.1016/j.jelectrocard.2005.12.007. Epub 2006 Aug 21. PMID 16919674
• Bodar V, Chen J, Gaziano JM, Albert C, Djousse L. Coffee Consumption and Risk of Atrial Fibrillation in the Physicians' Health Study. J Am Heart Assoc. 2019 Aug 6;8(15):e011346. doi: 10.1161/JAHA.118.011346. Epub 2019 Aug 5. PMID 31378120
• Larsson SC, Drca N, Jensen-Urstad M, Wolk A. Coffee consumption is not associated with increased risk of atrial fibrillation: results from two prospective cohorts and a meta-analysis. BMC Med. 2015 Sep 23;13:207. doi: 10.1186/s12916-015-0447-8. PMID 26394673

Идентификаторы

NCT: NCT05464940 · KCHRRF-COFFEE AF-0012

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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