ClinicalTrials.gg
RecruitingNCT05574153(META-MORE)Updated Oct 24, 2024

Metabolic Risk Factors and Myocardial Oxygenation Reserve

An observational study in Metabolic Syndrome, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Jun 2021; still recruiting 5 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
75
Ages
18 Years to 80 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Metabolic Syndrome

Browse trials for

Keywords

  • Myocardial oxygenation
03

In context

Metabolic Syndrome

2,011 studies on the registry are indexed under Metabolic Syndrome; 334 are open to participants now.

This study's planned enrollment of 75 is below the median of 200 across 469 observational studies indexed under Metabolic Syndrome.

Browse Metabolic Syndrome studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 420 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study population will be composed of participants with known MetS, based on the identified risk factors, and healthy volunteers.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
75 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient Participant

    Participants with known Metabolic Syndrome (MetS)

    Diagnostic Test: Cardiac MRI

  • Healthy Volunteers

    NonS-moking participants with no known pre-existing conditions and who do not take any medications

    Diagnostic Test: Cardiac MRI

Interventions

  • Diagnostic testCardiac MRI

    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.

    Also known as: Breathing Maneuvers

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What researchers measure

Primary outcomes

  1. Global and segmental Myocardial oxygenation reserve (MORE)

    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.

    Time frame: Baseline

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

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

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • The Reseach Institute of the McGill University Health Centre
    Montreal, Quebec H4A 3J1, Canada
    Recruiting
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2021 (actual). Primary completion is estimated for Dec 2024, 42 months after the start.

Of 141 non-industry observational studies under Metabolic Syndrome, half reached primary completion within 46 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 106. This study's planned 42 months is close to that.

Counting every sponsor, half of 152 studies reached it within 46 months; a quarter within 18 and three quarters within 106.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 6, 2022
First posted
Oct 10, 2022
StartActual
Jun 30, 2021
Primary completionEst.
Dec 30, 2024
CompletionEst.
Dec 30, 2024
Last update
Oct 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05574153
Responsible party
Matthias Friedrich (Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Oct 10, 2022
Start date
Jun 30, 2021
Primary completion
Dec 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Oct 24, 2024

Study contacts

Katherine Lindsay, Master
Contact
katherine.lindsay@mail.mcgill.ca
514-934-1934 ext. 37305
Elizabeth Konidis, Master
Contact
elisavet.konidis@muhc.mcgill.ca
514-934-1934 ext. 37305

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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