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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05574153

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

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. Our objectives for 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.

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome	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 Design

Study Type:

Observational

Anticipated Enrollment :

75 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jun 30, 2021

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	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

Arm

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

Other Names:

Breathing Maneuvers

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Reseach Institute of the McGill University Health Centre	Montréal	Quebec	Canada	H4A 3J1

Sponsors and Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matthias Friedrich, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

ClinicalTrials.gov Identifier:

NCT05574153

Other Study ID Numbers:

2021-7267

First Posted:

Oct 10, 2022

Last Update Posted:

Oct 10, 2022

Last Verified:

Oct 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Matthias Friedrich, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

Myocardial oxygenation

Additional relevant MeSH terms:

Metabolic Syndrome

Study Results

No Results Posted as of Oct 10, 2022