Effects of Carbon Monoxide Breathing on Blood Vessel Function

NCT03067701 | Completed Phase 1 FDA Drug

• 1 other identifier: Pro 46208
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

In healthy young adults 18-39 years of age, the investigators will determine if intermittent inhalation a 0.1% CO, from a 1-liter bag once every minute for 30-40 minutes, at a level that approaches the CO boost with hookah smoking, augments endothelial function, thus implicating CO as the major endothelial vasodilator substance in hookah smoke. Rationale: Our group has demonstrated (PRO36547) that in contrast to cigarette smoking, hookah smoking (tobacco heated with charcoal) acutely augments, rather than impairs, brachial artery FMD. Importantly, our data strongly implicate-but do not prove-that the augmentation in FMD is caused by CO. Therefore; the investigators would like to extend the scientific priority of this work by directly investigating cause and effect of CO breathing (similar levels than ones obtained after hookah smoking) on brachial artery FMD.

Conditions

Endothelial Dysfunction

Outcome Measures

Primary Outcomes (1)

• To determine the effect of intermittent inhalation of 0.1% CO from 1-liter bags on endothelial function measured by brachial artery flow mediated dilation.

  assessment of endothelial function measured by brachial artery flow-mediated dilation after 30-40 minutes of carbon monoxide adminstration

  immediate assessment of endothelial function measured by brachial artery flow-mediated dilation after 30-40 minutes of adminstration

Study Arms (1)

Carbon Monoxide Inhalation

EXPERIMENTAL

In healthy young adults 18-39 years of age, The Investigator will determine if intermittent inhalation a 0.1% CO, from a 1-liter bag once every minute for 30-40 minutes, at a level that approaches the CO boost with hookah smoking, augments endothelial function, thus implicating CO as the major endothelial vasodilator substance in hookah smoke.

Drug: Carbon Monoxide

Interventions

Carbon Monoxide DRUG

In healthy young adults 18-39 years of age, The investigator will determine if intermittent inhalation of 0.1% CO, from a 1-Liter bag once every minute for 30-40 min at a level that approaches the CO boost with hookah smoking, augments endothelial function.

Carbon Monoxide Inhalation

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age

You may not qualify if:

• History of cardiopulmonary, diabetes, dyslipidemia or psychiatric disease
• BP \> 140/90 mmHg
• BMI \<18.5 or \> 30 kg·m2
• Resting heart rate \> 100 beats/min
• Taking prescription medication
• Hemoglobin levels \< 11.6 g/dL
• Total cholesterol \> 240 or HDL \< 36
• Fasting glucose \>100 mg/dL or \<60 mg/dL
• Bilirubin \>1.2 mg/dL; albumin \< 3.5 or \> 5.5 g/dL; alkaline phosphatase (alk phos) \>125 IU/L; alanine aminotransferase (ALT) \> 45 U/L; aspartate aminotransferase (AST) \> 35 U/L
• Positive (+) toxicology screen
• Pregnant

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Related Publications (1)

• Rezk-Hanna M, Mosenifar Z, Benowitz NL, Rader F, Rashid M, Davoren K, Moy NB, Doering L, Robbins W, Sarna L, Li N, Chang LC, Elashoff RM, Victor RG. High Carbon Monoxide Levels from Charcoal Combustion Mask Acute Endothelial Dysfunction Induced by Hookah (Waterpipe) Smoking in Young Adults. Circulation. 2019 May 7;139(19):2215-2224. doi: 10.1161/CIRCULATIONAHA.118.037375.

  PMID: 30764644 DERIVED

MeSH Terms

Interventions

Carbon Monoxide

Intervention Hierarchy (Ancestors)

Carbon Compounds, Inorganic; Inorganic Chemicals; Gases; Oxides; Oxygen Compounds

Study Officials

• Ronald Victor, MD

  Director, Hypertension Center Associate Director, Cedars-Sinai Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2017
• First Posted: March 1, 2017
• Study Start: June 23, 2017
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: April 1, 2019

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)