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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

19 participants

Primary outcome timeframe

Pre- and post- the 30-minute smoking or vaping exposure sessions

Results posted on

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

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

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

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 sessions

Population: 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

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 sessions

Population: 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

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 sessions

Population: 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

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 sessions

Population: 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

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

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 sessions

Population: 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

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 sessions

Population: 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

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

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

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 sessions

Population: 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

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

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

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 sessions

Population: 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

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 sessions

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Electronic Hookah

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

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

Phone: 3102068654

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place