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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AA022222-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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Atrial fibrillation (AF) is the most common sustained arrhythmia in the United States and it has been associated with ethanol use. Understanding how ethanol affects the electrical properties of the heart and induces AF has important public health implications. The objective of this research is to investigate the mechanistic relationship between ethanol and atrial fibrillation in humans by performing a placebo controlled study looking at the electrical properties of the heart in patients receiving intravenous ethanol or placebo. The investigators hypothesize that ethanol increases the susceptibility of human myocardium to atrial fibrillation through electrophysiologic changes in the atrial myocardium in the acute setting.
The purpose of this study is to look for changes in the electrical properties of heart that may be caused by ethanol (commonly referred to as alcohol) and specifically how ethanol may trigger episodes of the most common abnormal heart rhythm, atrial fibrillation (AF). This study will demonstrate the mechanism of ethanol induced atrial fibrillation and clarify the health effects of one of the worlds' most popular drugs (ethanol). With this understanding, physicians may be able to better identify those patients most at risk for ethanol induced AF and target public health campaigns towards this vulnerable population.
Patients in this study will undergo an electrophysiologic study both prior to and after receiving either an ethanol or placebo infusion. This electrophysiology study will measure AF inducibility (the primary outcome), left and right atrial conduction times, and the atrial effective refractory period in multiple locations (AERP). The changes in the conduction times and AERPs (before and after study drug infusion) will be recorded as secondary outcomes.
About 100 people will participate in this study. 50 people will be randomized to receive intravenous ethanol, and 50 people will be randomized to receive an intravenous placebo. The placebo will be in the form of 0.45% saline solution ("half normal saline") and the alcohol will be in the form of 6% volume/volume ethanol in 0.45% saline solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded. |
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| Ethanol | Active Comparator | Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ethanol | Drug | 6% volume/volume ethanol in 0.45% saline solution. |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Atrial Fibrillation Induction | 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. | This will be measured after study drug (ethanol or placebo) infusion. The measurement will be performed within 1 hour of the infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Conduction Time | The atrial conduction time will be measured before and after study drug infusion, and the difference between the two times will be recorded as the Change in Conduction Time | This will be assessed during the experimental study from the Conduction Times that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion. |
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Inclusion Criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gregory M Marcus, MD, MAS | University of California, San Francisco | Principal Investigator |
| Jonathan W Dukes, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33516710 | Result | Marcus GM, Dukes JW, Vittinghoff E, Nah G, Badhwar N, Moss JD, Lee RJ, Lee BK, Tseng ZH, Walters TE, Vedantham V, Gladstone R, Fan S, Lee E, Fang C, Ogomori K, Hue T, Olgin JE, Scheinman MM, Hsia H, Ramchandani VA, Gerstenfeld EP. A Randomized, Double-Blind, Placebo-Controlled Trial of Intravenous Alcohol to Assess Changes in Atrial Electrophysiology. JACC Clin Electrophysiol. 2021 May;7(5):662-670. doi: 10.1016/j.jacep.2020.11.026. Epub 2021 Jan 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded. Placebo: The placebo with be 0.45% saline solution ("half normal saline"). |
| FG001 | Ethanol | Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded. Ethanol: 6% volume/volume ethanol in 0.45% saline solution. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded. Placebo: The placebo with be 0.45% saline solution ("half normal saline"). |
| BG001 | Ethanol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Atrial Fibrillation Induction | 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. | Posted | Count of Participants | Participants | This will be measured after study drug (ethanol or placebo) infusion. The measurement will be performed within 1 hour of the infusion. |
|
1 year post-ablation
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | The placebo will be administered to participants after the baseline electrophysiologic measurements are recorded. Placebo: The placebo with be 0.45% saline solution ("half normal saline"). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tamponade | Injury, poisoning and procedural complications | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gregory Marcus | University of California, San Francisco | (415) 353-2554 | Greg.Marcus@ucsf.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 30, 2017 | Jan 21, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 7, 2020 | Jan 21, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
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| Placebo | Drug | The placebo with be 0.45% saline solution ("half normal saline"). |
|
|
| Change in Atrial Effective Refractory Period (AERP) | The AERP will be measured before and after study drug infusion, and the difference between the two times will be recorded as the Change in AERP | This will be assessed during the experimental study from the AERPs that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion. |
Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded.
Ethanol: 6% volume/volume ethanol in 0.45% saline solution.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
|
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| Secondary | Change in Conduction Time | The atrial conduction time will be measured before and after study drug infusion, and the difference between the two times will be recorded as the Change in Conduction Time | Posted | Median | Inter-Quartile Range | ms | This will be assessed during the experimental study from the Conduction Times that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion. |
|
|
|
| Secondary | Change in Atrial Effective Refractory Period (AERP) | The AERP will be measured before and after study drug infusion, and the difference between the two times will be recorded as the Change in AERP | Posted | Mean | 95% Confidence Interval | ms | This will be assessed during the experimental study from the AERPs that are measured before and after the study drug infusion. The measurements will be performed within 1 hour of the infusion. |
|
|
|
| 0 |
| 50 |
| 0 |
| 50 |
| 1 |
| 50 |
| EG001 | Ethanol | Ethanol (alcohol) will be administered to participants after the baseline electrophysiologic measurements are recorded. Ethanol: 6% volume/volume ethanol in 0.45% saline solution. | 0 | 50 | 1 | 50 | 0 | 50 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D017606 |
| Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
| Distal coronary sinus (CSd) to CSp |
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| hRA to His bundle (His) |
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| hRA to low right atrium (lRA) |
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| LUPV to right upper pulmonary vein (RUPV) |
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| RUPV to CSd |
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| RUPV to His |
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