Metabolic Risk Factors and Myocardial Oxygenation Reserve

Metabolic Syndrome Clinical Trial

— (META-MORE)  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574153
• Other study ID #: 2021-7267
• Status: Recruiting
• Start date: June 30, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: March 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Katherine Lindsay, Master
• Phone: 514-934-1934
• Email: katherine.lindsay[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Syndrome

Intervention

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.

Locations

Country	Name	City	State
Canada	The Reseach Institute of the McGill University Health Centre	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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