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Completed

NCT Number: NCT04928183

The Impact of Carbon Monoxide and Altitude on Vascular Function

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

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2R3, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carbon monoxide rebreathe

Other

Carbon monoxide exposure to increase blood (Carboxyhemoglobin) COHb safely to ~10%

Other names: Schmidt-Prommer blood volume test

Sodium Nitroprusside

Drug

Bolus Sodium Nitroprusside (SNP) injection for endothelium-independent vasodilation measure

Other names: Nipride

Phenylephrine Hydrochloride

Drug

Bolus Phenylephrine injection for observe α1-mediated vasoconstriction during mild exercise

Primary outcomes

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

    Time frame: 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.

    Time frame: 15 minutes

    Blood flow within the brachial artery during rhythmic handgrip exercise.

  3. Change in brachial artery conductance following an infusion of phenylephrine

    Time frame: 5 min

    Change in brachial artery conductance following an infusion of phenylephrine

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Acronym: CarMA

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jun 16, 2021
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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