Trial Outcomes & Findings for Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function (NCT NCT01754922)

NCT ID: NCT01754922

Last Updated: 2017-02-28

Results Overview

Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge

• Recruitment status: COMPLETED
• Target enrollment: 50 participants
• Primary outcome timeframe: Pre/post exercise; cross-sectional
• Results posted on: 2017-02-28

Participant Flow

Participant milestones

Measure	Exposed Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter	Control OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
Overall Study STARTED	32	18
Overall Study COMPLETED	32	17
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Measure	Exposed Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter	Control OEF/OIF/OND Veterans deployed to regions other than Southwest Asia
Overall Study Adverse Event	0	1

Baseline Characteristics

Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function

Baseline characteristics by cohort

Measure	Exposed n=32 Participants Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter	Control n=18 Participants Veterans deployed to regions other than Iraq or Afghanistan or non-deployed	Total n=50 Participants Total of all reporting groups
Age, Continuous	34.8 years STANDARD_DEVIATION 8.1 • n=5 Participants	33.2 years STANDARD_DEVIATION 9.7 • n=7 Participants	34.6 years STANDARD_DEVIATION 8.7 • n=5 Participants
Gender Female	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Gender Male	26 Participants n=5 Participants	13 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	7 Participants n=5 Participants	14 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	4 Participants n=7 Participants	27 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	32 participants n=5 Participants	18 participants n=7 Participants	50 participants n=5 Participants
Tobacco Pack Years	1.45 Pack Years STANDARD_DEVIATION 3.42 • n=5 Participants	1.65 Pack Years STANDARD_DEVIATION 5.2 • n=7 Participants	1.5 Pack Years STANDARD_DEVIATION 4.08 • n=5 Participants

PRIMARY outcome

Timeframe: Pre/post exercise; cross-sectional

Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge

Outcome measures

Measure	Exposed n=32 Participants Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter	Control n=18 Participants Veterans deployed to regions other than Iraq and Afghanistan or non-deployed
FEV1 Pre-Exercise FEV1	0.94 percentage of predicted normal values Standard Deviation .16	1.08 percentage of predicted normal values Standard Deviation .16
FEV1 Post-Exercise FEV1	0.95 percentage of predicted normal values Standard Deviation 0.18	1.09 percentage of predicted normal values Standard Deviation 0.17

PRIMARY outcome

Timeframe: At peak exercise; cross-sectional

Population: 4 participants were excluded due to failure to meet maximal exercise criteria (3 from exposed, 1 from control). Therefore, we removed these individuals from the final analysis.

Maximal oxygen consumption measured during exercise

Outcome measures

Measure	Exposed n=29 Participants Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter	Control n=17 Participants Veterans deployed to regions other than Iraq and Afghanistan or non-deployed
VO2 Peak	33.79 ml/min/kg Standard Deviation 8.6	34.49 ml/min/kg Standard Deviation 10.4

PRIMARY outcome

Timeframe: Resting baseline; cross-sectional

Population: Signal quality of the the electrocardiogram was poor for 3 individuals; therefore, their data were removed from final analysis.

Ratio of low-frequency to high-frequency power for heart rate variability

Outcome measures

Measure	Exposed n=29 Participants Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter	Control n=18 Participants Veterans deployed to regions other than Iraq and Afghanistan or non-deployed
Heart Rate Variability	2.02 Ratio Standard Deviation 1.7	1.13 Ratio Standard Deviation 1.1

Adverse Events

Exposed

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Exposed n=32 participants at risk Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter	Control n=18 participants at risk OEF/OIF/OND Veterans deployed to regions other than Southwest Asia or non-deployed
Psychiatric disorders Psychiatric emergency	0.00% 0/32	5.6% 1/18 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Dr. Michael Falvo

VA NJ Health Care System

Phone: 973-676-1000

Email: Michael.Falvo@va.gov

Results disclosure agreements

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