Trial Outcomes & Findings for The Cardiovascular Effects of Electronic Hookah Vaping (NCT NCT03690427)
NCT ID: NCT03690427
Last Updated: 2023-08-16
Results Overview
Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function. Baseline diameter and velocity were recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.
COMPLETED
NA
19 participants
Pre- and post- the 30-minute smoking or vaping exposure sessions
2023-08-16
Participant Flow
Participants were recruited through advertisements posted at Southern California colleges and universities, as well as social media websites, from December 2018 to August 2020.
Participant milestones
| Measure |
Traditional Followed by Electronic Hookah
Participants were invited to smoke a 30-minute traditional charcoal-heated hookah-smoking session, followed by a 30-minute electronic hookah vaping session.
To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.
|
Electronic Followed by Traditional Hookah
Participants were invited to vape a 30-minute electronic hookah session, followed by a 30-minute traditional charcoal-heated hookah smoking session.
To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.
|
|---|---|---|
|
Overall Study
STARTED
|
9
|
10
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Traditional Followed by Electronic Hookah
Participants were invited to smoke a 30-minute traditional charcoal-heated hookah-smoking session, followed by a 30-minute electronic hookah vaping session.
To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.
|
Electronic Followed by Traditional Hookah
Participants were invited to vape a 30-minute electronic hookah session, followed by a 30-minute traditional charcoal-heated hookah smoking session.
To mitigate the impact of carryover effects, the two sessions were separated by a minimum of 7-days.
|
|---|---|---|
|
Overall Study
Requested by subject not to complete traditional hookah
|
0
|
2
|
Baseline Characteristics
The Cardiovascular Effects of Electronic Hookah Vaping
Baseline characteristics by cohort
| Measure |
All Study Participants
n=19 Participants
Participants who were randomized to either smoke hookah first followed by vape hookah or vape hookah first followed by smoke hookah.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
17 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (1 participant had suboptimal ultrasound images from the e-hookah group; and 2 did not have images from the traditional hookah group)
Using ultrasound, FMD of the brachial artery induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function. Baseline diameter and velocity were recorded for 45 seconds and resumed 30 seconds before cuff deflation and continuously for 2 minutes after deflation to obtain true peak vasodilatory response.
Outcome measures
| Measure |
Electronic Hookah
n=18 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=17 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Flow-Mediated Dilation (FMD)
FMD after exposure session
|
4.79 percentage of arterial diameter
Standard Error 0.58
|
7.31 percentage of arterial diameter
Standard Error 0.82
|
|
Flow-Mediated Dilation (FMD)
FMD before exposure session
|
6.11 percentage of arterial diameter
Standard Error 0.66
|
5.89 percentage of arterial diameter
Standard Error 1.02
|
PRIMARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (unable to obtain data on 4 participants in the e-hookah group)
Using applanation tonometry, cf-PWV was used to measure central arterial stiffness.
Outcome measures
| Measure |
Electronic Hookah
n=13 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=17 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Carotid-Femoral Pulse Wave Velocity (Cf-PWV)
cf-PWV before exposure session
|
8.20 m/sec
Standard Error 0.26
|
8.15 m/sec
Standard Error 0.20
|
|
Carotid-Femoral Pulse Wave Velocity (Cf-PWV)
cf-PWV after exposure session
|
8.94 m/sec
Standard Error 0.33
|
8.71 m/sec
Standard Error 0.23
|
PRIMARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (unable to obtain data on 4 participants in the e-hookah group)
Capacity was determined as the ability of HDL to inhibit LDL-induced oxidation of dihydrodichlorofluorescein into the fluorescent dichlorofluorescein. Capacity was expressed as an HDL oxidative index, determined by the ratio of dichlorofluorescein fluorescence in the presence and absence of HDL. An index of \< 1.0 denotes protective antioxidant HDL, whereas an index of \> 1.0 indicates pro-oxidant HDL.
Outcome measures
| Measure |
Electronic Hookah
n=13 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=17 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
HDL Oxidant Index (HOI)
HOI before exposure session
|
0.57 index
Standard Error 0.05
|
0.56 index
Standard Error 0.06
|
|
HDL Oxidant Index (HOI)
HOI after exposure session
|
0.58 index
Standard Error 0.06
|
0.52 index
Standard Error 0.05
|
PRIMARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (unable to obtain data on 4 participants in the e-hookah group)
PON-1 activity was determined by the ability of PON-1, associated with HDL, to hydrolyze paraoxon substrate. The hydrolysis of paraoxon (diethyl-p-nitrophenyl phosphate) to p-nitrophenol by PON-1 was determined by incubating 5 mL of plasma with 1.0 mM paraoxon in 100 mM tris-HCl buffer (pH, 8.5). Unit of Measure: expressed as micromoles of p-nitrophenol formed per minute for every 1 mL plasma.
Outcome measures
| Measure |
Electronic Hookah
n=13 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=17 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Paraoxonase-1 (PON-1) Activity
PON-1 before exposure session
|
1071.24 units/mL:see Outcome Measure Description
Standard Error 188.79
|
709.32 units/mL:see Outcome Measure Description
Standard Error 112.43
|
|
Paraoxonase-1 (PON-1) Activity
PON-1 after exposure session
|
1151.73 units/mL:see Outcome Measure Description
Standard Error 207.98
|
701.29 units/mL:see Outcome Measure Description
Standard Error 110.67
|
PRIMARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessions.Population: All study participants who completed study visits (unable to obtain data on 1 participant from the e-hookah group and 3 participants from the traditional hookah group).
Arylesterase activity (lipid peroxidation biomarker) was determined by the rate of hydrolysis of phenyl acetate to phenol. Briefly, 4 mL plasma was incubated with 3.5 mM phenyl acetate in 9 mM Tris-HCl buffer (pH, 8.0) containing 0.9 mM CaCl2 at RT. The kinetics of phenol formation were determined by recording the absorbance at 270 nm every 15 s for 2 min. Unit of Measure: nanomoles of product formed per minute per milliliter of plasma.
Outcome measures
| Measure |
Electronic Hookah
n=16 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=14 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Arylesterase Activity
Arylesterase activity before exposure session
|
277.36 units/mL:see Outcome Measure Description
Standard Error 14.26
|
281.38 units/mL:see Outcome Measure Description
Standard Error 19.33
|
|
Arylesterase Activity
Arylesterase activity after exposure session
|
295.78 units/mL:see Outcome Measure Description
Standard Error 16.78
|
285.06 units/mL:see Outcome Measure Description
Standard Error 16.78
|
PRIMARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (unable to obtain data on 2 participants in the traditional hookah group)
Plasma hs-CRP (inflammatory biomarker)
Outcome measures
| Measure |
Electronic Hookah
n=17 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=15 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
High-sensitivity C-reactive Protein (Hs-CRP) Levels
hs-CRP before exposure session
|
0.72 mg/L
Standard Error 0.12
|
0.77 mg/L
Standard Error 0.19
|
|
High-sensitivity C-reactive Protein (Hs-CRP) Levels
hs-CRP after exposure session
|
0.76 mg/L
Standard Error 0.13
|
0.77 mg/L
Standard Error 0.19
|
PRIMARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (unable to obtain data on 1 participant in the e-hookah group)
Plasma TNFα (inflammatory biomarker)
Outcome measures
| Measure |
Electronic Hookah
n=16 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=17 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Tumor Necrosis Factor-α (TNFα) Concentrations
TNFα after exposure session
|
0.76 pg/mL
Standard Error 0.08
|
0.82 pg/mL
Standard Error 0.08
|
|
Tumor Necrosis Factor-α (TNFα) Concentrations
TNFα before exposure session
|
0.69 pg/mL
Standard Error 0.06
|
0.85 pg/mL
Standard Error 0.08
|
SECONDARY outcome
Timeframe: Effect of FMD with e-hookah vaping examined after pretreatment of intravenous infusion of antioxidant ascorbic acid (administered over 60 minutes at 0.5 mL min-1)Population: A subset of participants, who completed the e-hookah vaping protocol.
Using ultrasound, FMD of the brachial artery, induced by reactive hyperemia, was used to measure endothelium-dependent vasodilator function after intravenous infusion of antioxidant ascorbic acid. Infusion of antioxidant ascorbic acid was done before the e-hookah vaping session.
Outcome measures
| Measure |
Electronic Hookah
n=11 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Flow-Mediated Dilation (FMD)
FMD before e-hookah vaping
|
9.46 percentage of arterial diameter
Standard Error 0.87
|
—
|
|
Flow-Mediated Dilation (FMD)
FMD after e-hookah vaping
|
8.74 percentage of arterial diameter
Standard Error 0.84
|
—
|
SECONDARY outcome
Timeframe: Pre- and post- sublingual administration of nitroglycerin (0.15 mg), which was administrated before and after e-hookah vaping.Population: A subset of participants, who completed the e-hookah vaping protocol.
As a control test for the assessment of endothelium-dependent vasodilator function, using ultrasound the brachial artery, endothelium-independent dilatation was assessed by administering sublingual nitroglycerin. This measure was assessed 10 minutes after FMD testing. Ultrasound images were recorded continuously for a total of 10 minutes
Outcome measures
| Measure |
Electronic Hookah
n=8 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Endothelium-independent Vasodilator Function (Control Test for Endothelium-dependent Vasodilator Function)
Dilation before e-hookah vaping
|
27.15 percentage of arterial diameter
Standard Error 1.98
|
—
|
|
Endothelium-independent Vasodilator Function (Control Test for Endothelium-dependent Vasodilator Function)
Dilation after e-hookah vaping
|
25.17 percentage of arterial diameter
Standard Error 1.87
|
—
|
SECONDARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (unable to obtain data on 4 participants in the e-hookah group and 1 in the traditional hookah group)
AI was used to measure central stiffness. It was calculated as the ratio of augmentation pressure (difference between the second and first systolic peaks of the aortic pressure waveform) and pulse pressure expressed as a percentage.
Outcome measures
| Measure |
Electronic Hookah
n=13 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=16 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Augmentation Index (AI)
AI before exposure session
|
7.97 percentage of the pulse pressure
Standard Deviation 2.97
|
7.79 percentage of the pulse pressure
Standard Deviation 2.54
|
|
Augmentation Index (AI)
AI after exposure session
|
13.55 percentage of the pulse pressure
Standard Deviation 3.24
|
10.66 percentage of the pulse pressure
Standard Deviation 2.98
|
SECONDARY outcome
Timeframe: A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).Population: All study participants who completed study visits (unable to obtain data on 5 participants in the e-hookah group)
Plasma IL-6 (inflammatory biomarker).
Outcome measures
| Measure |
Electronic Hookah
n=12 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=17 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Interleukin 6 (IL-6) Levels
|
0.13 pg/mL
Standard Error 0.08
|
0.04 pg/mL
Standard Error 0.06
|
SECONDARY outcome
Timeframe: A change between two points is reported below (e.g., value at post-exposure session minus value at pre-exposure session).Population: All study participants who completed study visits (unable to obtain data on 5 participants in the e-hookah group)
Serum IL-10 (anti-inflammatory biomarker)
Outcome measures
| Measure |
Electronic Hookah
n=12 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=17 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Interleukin 10 (IL-10) Levels
|
0.03 pg/mL
Standard Error 0.03
|
-0.01 pg/mL
Standard Error 0.01
|
SECONDARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (unable to obtain data on 1 participant in the e-hookah group and 1 participant in the traditional hookah group)
Plasma nicotine levels (smoking or vaping exposure biomarker)
Outcome measures
| Measure |
Electronic Hookah
n=16 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=16 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Nicotine Levels
Plasma nicotine before exposure session
|
0.59 ng/mL
Standard Error 0.09
|
0.82 ng/mL
Standard Error 0.24
|
|
Nicotine Levels
Plasma nicotine after exposure session
|
5.83 ng/mL
Standard Error 0.96
|
6.96 ng/mL
Standard Error 1.11
|
SECONDARY outcome
Timeframe: Pre- and post- the 30-minute smoking or vaping exposure sessionsPopulation: All study participants who completed study visits (unable to obtain data on 1 participant in the e-hookah group; and 1 participant in the traditional hookah group)
Exhaled CO levels (smoking or vaping exposure biomarker)
Outcome measures
| Measure |
Electronic Hookah
n=16 Participants
Participants who completed a 30-minute e-hookah vaping session
|
Traditional Hookah
n=16 Participants
Participants who completed a 30-minute combustible hookah smoking session
|
|---|---|---|
|
Carbon Monoxide (CO) Levels
CO before exposure session
|
2.58 ppm
Standard Error 0.27
|
3.38 ppm
Standard Error 0.49
|
|
Carbon Monoxide (CO) Levels
CO after exposure session
|
2.31 ppm
Standard Error 0.20
|
40.19 ppm
Standard Error 6.69
|
Adverse Events
Traditional Hookah
Electronic Hookah
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mary Rezk-Hanna, PhD
University of California, Los Angeles
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place