Impact of Intravenous Caffeine on Atrial Electrical Properties and Potential Arrythmia Induction in Patients With Paroxysmal Atrial Fibrillation: The COFFEE-AF Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 9
- Primary Endpoint
- Number of Participants With Atrial Fibrillation Induction
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 21 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Group assigned to receive caffeine
Intervention: Intravenous caffeine (Other)
Group assigned to receive masked placebo
Intervention: Masked Placebo (Other)
Outcomes
Primary Outcomes
Number of Participants With Atrial Fibrillation Induction
Time Frame: 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.
Secondary Outcomes
- 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)