Metabolic Risk Factors and Myocardial Oxygenation Reserve
(META-MORE)
1 other identifier
observational
75
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2021
CompletedFirst Submitted
Initial submission to the registry
October 6, 2022
CompletedFirst Posted
Study publicly available on registry
October 10, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2024
CompletedOctober 24, 2024
October 1, 2024
3.5 years
October 6, 2022
October 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
Baseline
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.
Baseline
Study Arms (2)
Patient Participant
Participants with known Metabolic Syndrome (MetS)
Healthy Volunteers
NonS-moking participants with no known pre-existing conditions and who do not take any medications
Interventions
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.
Eligibility Criteria
The study population will be composed of participants with known MetS, based on the identified risk factors, and healthy volunteers.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Reseach Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 6, 2022
First Posted
October 10, 2022
Study Start
June 30, 2021
Primary Completion
December 30, 2024
Study Completion
December 30, 2024
Last Updated
October 24, 2024
Record last verified: 2024-10
Data Sharing
- IPD Sharing
- Will not share