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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Diagnostic test: Cardiac MRI

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.

• Study Type: Observational
• Enrollment (Estimated): 75

Contacts and Locations

• Study Contact: Name: Katherine Lindsay, Master; Phone Number: 37305 514-934-1934; Email: katherine.lindsay@mail.mcgill.ca
• Study Contact Backup: Name: Elizabeth Konidis, Master; Phone Number: 37305 514-934-1934; Email: elisavet.konidis@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3J1
      • Recruiting
      • The Reseach Institute of the McGill University Health Centre
      • Contact: Katherine Lindsay, Master; Phone Number: 37305 514-9341934; Email: katherine.lindsay@mail.mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient Participant; Participants with known Metabolic Syndrome (MetS)	Diagnostic test: Cardiac 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.; Other Names: Breathing Maneuvers
Healthy Volunteers; NonS-moking participants with no known pre-existing conditions and who do not take any medications	Diagnostic test: Cardiac 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.; Other Names: Breathing Maneuvers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2021
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Myocardial oxygenation
• Additional Relevant MeSH Terms: Metabolic Diseases; Glucose Metabolism Disorders; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 2021-7267

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No