Coffee and Real-time Atrial and Ventricular Ectopy (CRAVE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03671759|
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : December 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Premature Atrial Contractions Premature Ventricular Contractions||Behavioral: Start: On Caffeine Behavioral: Start: Off Caffeine||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coffee and Real-time Atrial and Ventricular Ectopy|
|Estimated Study Start Date :||February 1, 2019|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Experimental: N-of-1
Participants will be randomized in two-day blocks to consume then avoid caffeine ("Start: On Caffeine") or avoid then consume caffeine ("Start: Off Caffeine"). Using an N-of-1 strategy delivered by the NIH-funded, UCSF-run Eureka platform utilizing a mobile smartphone-based application, participants will receive instructions and answer questions to help us understand the relationship between caffeine and heart rhythm.
Behavioral: Start: On Caffeine
In this two-day block, participants will be instructed to consume caffeine for one day and avoid caffeine the next day.
Behavioral: Start: Off Caffeine
In this two-day block, participants will be instructed to avoid caffeine for one day and consume caffeine the next day.
- Change in cardiac ectopy burden [ Time Frame: 2 weeks ]Participants will be wearing a continuously recording ECG monitor for two weeks. The primary outcome will be change in ectopy burden due to caffeine consumption or avoidance during the enrollment period.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03671759
|Contact: Christina Fangfirstname.lastname@example.org|
|United States, California|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Gregory M Marcus, MD, MAS||University of California, San Francisco|
|Principal Investigator:||David Rosenthal, MD||University of California, San Francisco|