N/A
N=450
E-Cigarette Effects on Markers of Cardiovascular and Pulmonary Disease
Tobacco Use · E-Cigarette Use · Cardiovascular Diseases · Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT03863509 ↗Enrolled (actual)
450
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Brachial Artery Flow-Mediated Dilation (FMD)- Pre Challenge — 4.25; 4.89; 5.31 Percent change from resting diameter — p=.494
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Cigarettes (Behavioral); E-Cigarettes (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Brachial Artery Flow-Mediated Dilation (FMD)- Pre Challenge |
4.25; 4.89; 5.31 | .494 |
| PRIMARY Forced Expiratory Volume (FEV1)- Pre Challenge |
82.9; 93.8; 92.0 | 0.001 sig |
| PRIMARY Carotid Intima-Media Thickness (IMT) |
0.67; 0.54; 0.54 | .074 |
| PRIMARY Changes in Systolic Blood Pressure Pre- and Post-challenge. |
118.4; 120.25; 119.74; 125.40; 126.43; 132.00 | .002 sig |
| PRIMARY Changes in Diastolic Blood Pressure Pre- and Post-challenge. |
70.40; 72.51; 71.12; 75.31; 76.64; 81.04 | 0.003 sig |
| PRIMARY Changes in Heart Rate Pre- and Post-challenge. |
59.57; 58.42; 58.34; 63.17; 65.31; 69.15 | < .001 sig |
| PRIMARY Changes in Brachial Artery Diameter Pre- and Post-challenge |
0.378; 0.370; 0.388; 0.378; 0.410; 0.398 | 0.002 sig |
| PRIMARY Changes in Brachial Artery Flow Mediated Dilation (FMD) Pre- and Post-challenge |
5.31; 4.22; 4.89; 4.62; 4.25; 3.57 | 0.175 |
| PRIMARY Changes in Percent of Sequential Heart Cycles That Differ by More Than 50 ms From Each Other in Length (PNN50, %) Pre- and Post-challenge |
33.64; 36.46; 34.82; 31.02; 18.46; 15.45 | <0.001 sig |
| PRIMARY Changes in Root Mean Square of Successive Differences Between Normal Heart Beats (RMSSD, ms) Pre- and Post-challenge |
66.44; 71.10; 71.20; 64.40; 48.29; 44.44 | 0.001 sig |
| PRIMARY Changes in Heart Rate Variability Standing Ratio Pre- and Postchallenge |
1.57; 1.55; 1.55; 1.51; 1.38; 1.34 | .182 |
| PRIMARY Changes in Predicted Forced Expiatory Volume in 1 Second (FEV1, %) Pre- and Post-challenge |
92.00; 91.12; 93.83; 89.76; 82.91; 80.43 | 0.017 sig |
| PRIMARY Changes in Forced Vital Capacity (FVC, %) Pre- and Post-Challenge. |
96.45; 95.00; 98.25; 96.77; 90.28; 87.88 | .771 |
| PRIMARY Changes in Ratio Between Predicted Forced Expiatory Volume in First Second and Predicted Total Vital Capacity (FEV1/FVC Ratio) Pre- and Post-challenge |
95.74; 95.93; 95.66; 92.23; 91.18; 90.89 | 0.001 sig |
| PRIMARY Changes in Percent Predicted Forced Expiratory Flow at 25 and 75% of the Pulmonary Volume (FEF 25-75, %) Pre and Pos-challenge |
86.91; 85.17; 87.94; 80.20; 71.09; 68.49 | 0.014 sig |
| PRIMARY Changes in Fractional Exhaled Nitric Oxide (FeNO, Ppb) Pre- and Post-challenge |
16.17; 16.97; 14.51; 13.64; 9.67; 9.93 | 0.001 sig |
| SECONDARY Heart Rate (HR) |
65.3; 58.3; 59.6 | < .001 sig |
| SECONDARY Heart Rate Variability (HRV) - Pre Product Use Challenge |
11.4; 37.1; 31.0 | .035 sig |
| SECONDARY Systolic Blood Pressure (BP) |
126.4; 119.7; 118.4 | .549 |
| SECONDARY Forced Vital Capacity (FVC) |
90.3; 98.3; 96.5 | .022 sig |
| SECONDARY Fractional Exhaled Nitric Oxide (FeNO) |
9.7; 14.5; 16.2 | < .001 sig |
| SECONDARY Autonomic Measures - RMSSD |
43.6; 63.3; 58.3 | .150 |
| SECONDARY Arterial Pulse Wave Analysis (PWA), Augmentation Index (at 75 Bpm, %) |
19.5; 0.50; 1.00 | < .001 sig |
| SECONDARY Exercise Treadmill Stress Test (ETT)-Peak METS |
8.39; 10.29; 11.06 | < .001 sig |
| SECONDARY Diastolic Blood Pressure (DBP) |
76.6; 71.1; 70.4 | .199 |
| SECONDARY Peak Rate Pressure Product (RPP, Peak Heart Rate Multiplied by Peak Systolic Blood Pressure) |
249.99; 284.76; 290.86 | <0.001 sig |
| SECONDARY Heart Rate Reserve (%) |
83.25; 87.89; 91.72 | <0.001 sig |
| SECONDARY 60 Seconds Heart Rate Recovery (Beats Per Minute) |
19.62; 26.74; 28.06 | <0.001 sig |
Summary
This study is designed to enhance the understanding of the possible health effects of e-cigarette use by relating the acute and long-term use of e-cigarettes and conventional cigarettes ("products") to well-validated cardiovascular and pulmonary disease biomarkers. Participants will be enrolled in 3 groups: exclusive e-cigarette users, exclusive cigarette smokers, and a control group of never-users. Participants can expect up to 4 weeks of study participation.
Eligibility Criteria
Inclusion Criteria
- able to read and write English
- no plans to quit smoking and/or e-cig use in the next month
- not using cigars/smokeless/snus tobacco >/= 1 time per week
- having a stable pattern of current product use
- able to walk at least 2 blocks without assistance or stopping
- Specific to Exclusive Smokers:
- smokes daily
- >/= 5 cigs/day for last 6 months
- /= 5 ppm carbon monoxide (CO)
- Cotinine > 100 ng/ml
- Specific to Exclusive E-cig users:
- /= 5 days per week E-cig use for last 3 months
- 100 ng/ml
- Specific to Never-users
- 5 years
- < 3 E-cig uses in a lifetime
- </= 4 ppm CO
- Cotinine < 100 ng/ml
Exclusion Criteria
- current use of a smoking cessation medication
- women who are pregnant or plan to get pregnant in the coming month
- women who might be pregnant
- incarcerated individuals
- history of sarcoidosis in past 5 years, or active interstitial lung/pulmonary fibrosis
- history of positive Coronavirus-19 test
Data sourced from ClinicalTrials.gov (NCT03863509). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.