CarMA: The Impact of Carbon Monoxide and Altitude on Vascular Function

Sponsor
University of Alberta (Other)
Overall Status
Completed
CT.gov ID
NCT04928183
Collaborator
(none)
19
1
2
11.2
1.7

Study Details

Study Description

Brief Summary

The CarMA (Carbon Monoxide and Altitude) Study aims to observe the vascular effects of carbon monoxide exposure at low and high altitudes.

Condition or Disease Intervention/Treatment Phase
  • Other: Carbon monoxide rebreathe
  • Drug: Sodium Nitroprusside
  • Drug: Phenylephrine Hydrochloride
N/A

Detailed Description

Each year, millions of people make journeys from low altitude regions to high altitude for recreation, travel, and religious pilgrimage. Carbon monoxide (CO) is commonly associated with cigarette smoke, exhaust fumes, and is viewed as a life-threatening toxic gas. Exposure to CO occurs during travel to and during activities common in high-altitude travel and pilgrimage including vehicle fumes, incense, and second-hand smoke exposure. High altitude exposure and CO exposure have been observed independently to have complex and opposing effects on vascular endothelial function. Observation of these stimuli together in a controlled environment may allow for further understanding of the underlying mechanisms of vascular physiology and adaptations to both high-altitude and CO exposure. The CarMA (Carbon Monoxide and Altitude) Study aims to observe the vascular effects of carbon monoxide exposure at low and high altitudes. Recently, other studies have showed a significant improvement in flow mediated dilation (FMD) with acute exposure to low levels of CO To date, no research has been presented concerning the effect of CO on vascular function at altitude. The present study aims to observe the effect of acute carbon monoxide exposure on 1) flow mediated dilation, 2) conduit artery flow in exercise induced reactive hyperemia at sea level and at altitude, and 3) the effect of CO on vascular function in a high altitude dwelling (sherpa) population.

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Participants will partake in both room air and CO exposure on 2 separate visits.Participants will partake in both room air and CO exposure on 2 separate visits.
Masking:
Single (Participant)
Masking Description:
Participant will not be aware of which rebreathe treatment (CO or Room Air) they are receiving.
Primary Purpose:
Basic Science
Official Title:
The Impact of Carbon Monoxide and Altitude on Vascular Function
Actual Study Start Date :
Jun 10, 2021
Actual Primary Completion Date :
Aug 1, 2021
Actual Study Completion Date :
May 18, 2022

Arms and Interventions

Arm Intervention/Treatment
Sham Comparator: Room Air Rebreathe

Rebreathe protocol will be completed with a room air syringe rather than CO

Drug: Sodium Nitroprusside
Bolus Sodium Nitroprusside (SNP) injection for endothelium-independent vasodilation measure
Other Names:
  • Nipride
  • Drug: Phenylephrine Hydrochloride
    Bolus Phenylephrine injection for observe α1-mediated vasoconstriction during mild exercise

    Experimental: CO Rebreathe

    Rebreathe protocol will be completed with Carbon Monoxide

    Other: Carbon monoxide rebreathe
    Carbon monoxide exposure to increase blood (Carboxyhemoglobin) COHb safely to ~10%
    Other Names:
  • Schmidt-Prommer blood volume test
  • Drug: Sodium Nitroprusside
    Bolus Sodium Nitroprusside (SNP) injection for endothelium-independent vasodilation measure
    Other Names:
  • Nipride
  • Drug: Phenylephrine Hydrochloride
    Bolus Phenylephrine injection for observe α1-mediated vasoconstriction during mild exercise

    Outcome Measures

    Primary Outcome Measures

    1. Change in brachial artery diameter (assessed via ultrasound) following release of arterial occlusion [15 minutes]

      Change in brachial artery diameter (assessed via ultrasound) following release of arterial occlusion

    2. Blood flow within the brachial artery during rhythmic handgrip exercise. [15 minutes]

      Blood flow within the brachial artery during rhythmic handgrip exercise.

    3. Change in brachial artery conductance following an infusion of phenylephrine [5 min]

      Change in brachial artery conductance following an infusion of phenylephrine

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Between the ages of 18-50 years

    • No medical history of cardiovascular, respiratory, nervous system, or metabolic disease.

    • Women must be pre-menopausal.

    Exclusion Criteria:
    • Participants with any known cardiovascular, respiratory, nervous system, or metabolic disease.

    • Having travelled above 2,000m within 1 month of testing at low and high altitude.

    • Women who are pregnant, confirmed by a pregnancy test.

    • Women who are post-menopausal.

    • Participants that are classified as obese (body mass index > 30 kg/m2).

    • Participants who are current daily smokers.

    • Participants that are currently taking monoamine (MAO) inhibitors, or tricyclic antidepressants.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Alberta Edmonton Alberta Canada T6G 2R3

    Sponsors and Collaborators

    • University of Alberta

    Investigators

    • Principal Investigator: Sean van Diepen, MD, MSc, University of Alberta
    • Principal Investigator: Craig Steinback, PhD, University of Alberta

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Alberta
    ClinicalTrials.gov Identifier:
    NCT04928183
    Other Study ID Numbers:
    • Pro00096251
    First Posted:
    Jun 16, 2021
    Last Update Posted:
    May 25, 2022
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 25, 2022