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NCT Number: NCT05574153

Metabolic Risk Factors and Myocardial Oxygenation Reserve

The purpose of this study is to use MRI images using the OS-CMR technique to view the differences in the hearts of healthy volunteers and participants with a condition called Metabolic Syndrome. The objectives of this project are to compare these two groups and to view how health risks, blood test results, and the time since a Metabolic diagnosis can affect heart health.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Reseach Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location status: Recruiting

Location contact

Katherine Lindsay, Master

CONTACT

[email protected]

514-9341934 ext. 37305

About this study

Myocardial oxygenation changes during vasoactive breathing maneuvers, observed with oxygenation-sensitive cardiac MRI, will be identified and compared between individuals considered healthy and those fitting the criteria of the Metabolic Syndrome.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

Patient Participants:

  • Age 18-80
  • Informed Consent
  • Diagnosis of MetS (through at least 3 MetS characteristics (abdominal obesity, high triglyceride level, low HDL cholesterol, high systolic blood pressure, and high fasting glucose levels)

Healthy Volunteers:

  • Age 18-80
  • No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system
  • No Smoking

Exclusion criteria

  • General MRI contraindications*
  • Pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, knowledge or suspicion of pregnancy.
  • Consumption of caffeine (coffee, tea, cocoa, chocolate, "energy drink") during the 12 hours prior to the exam

Treatment and study plan

Cardiac MRI

Diagnostic Test

Participants will undergo an oxygenation-sensitive cardiac MRI and, during the scan, perform a vasoactive breathing maneuver composed of a period of paced hyperventilation followed by a voluntary maximal breath hold.

Other names: Breathing Maneuvers

Primary outcomes

  1. Global and segmental Myocardial oxygenation reserve (MORE)

    Time frame: Baseline

    A t-test will be used to assess the difference in global and segmental MORE, at rest, during hyperventilation, and throughout breath hold, between healthy and volunteers and MetS patients.

  2. Relation between Breathing maneuver induced MORE and known MetS risk factors.

    Time frame: Baseline

    A linear regression will assess the relation between Breathing maneuver induced MORE and known MetS risk factors, biomarkers, and time since diagnosis.

Study contacts

Contact information is provided by the study sponsor or research team.

Elizabeth Konidis, Master

CONTACT

[email protected]

514-934-1934 ext. 37305

Katherine Lindsay, Master

CONTACT

[email protected]

514-934-1934 ext. 37305

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Official study title

Metabolic Risk Factors and Myocardial Oxygenation Reserve (META-MORE)

Acronym: (META-MORE)

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Oct 10, 2022
Registry last updated
Oct 24, 2024

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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