Metabolic Risk Factors and Myocardial Oxygenation Reserve

Recruiting

• Conditions: Metabolic Syndrome
• Interventions: Diagnostic Test: Cardiac MRI

• Registration Number: NCT05574153
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

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.

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 Timeline

• Study Start: 2021-06-30
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 75

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patient Participant	Cardiac MRI	Participants with known Metabolic Syndrome (MetS)
Healthy Volunteers	Cardiac MRI	NonS-moking participants with no known pre-existing conditions and who do not take any medications

Primary Outcome Measures

Name	Time	Method
Global and segmental Myocardial oxygenation reserve (MORE)	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.
Relation between Breathing maneuver induced MORE and known MetS risk factors.	Baseline	A linear regression will assess the relation between Breathing maneuver induced MORE and known MetS risk factors, biomarkers, and time since diagnosis.

Trial Locations

Locations (1)

The Reseach Institute of the McGill University Health Centre; 🇨🇦 Montréal, Quebec, Canada