Metabolic Syndrome(META-MORE)NCT05574153
Metabolic Risk Factors and Myocardial Oxygenation Reserve
An observational study of Metabolic Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Cardiac MRI
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- 30 Jun 2021to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population will be composed of participants with known MetS, based on the identified risk factors, and healthy volunteers.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Reseach Institute of the McGill University Health Centre
Montreal, Quebec, H4A 3J1
Katherine Lindsay, Master, 514-9341934 ext. 37305, katherine.lindsay@mail.mcgill.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- Cardiac MRI
- Keywords
- Myocardial oxygenation
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDiagnostic test
Also called Breathing Maneuvers
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Participant | Participants with known Metabolic Syndrome (MetS) Receives: Diagnostic Test: Cardiac MRI | |
| Healthy Volunteers | NonS-moking participants with no known pre-existing conditions and who do not take any medications Receives: Diagnostic Test: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start30 Jun 2021
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthias Friedrich, McGill University Health Centre/Research Institute of the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574153
- Sponsor's protocol ID
- 2021-7267
- Acronym
- (META-MORE)
- Status last verified
- Oct 2024
- First submitted
- 6 Oct 2022
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Risk Factors and Myocardial Oxygenation Reserve (META-MORE)
- ClinicalTrials.gov ID
- NCT05574153
- Acronym / sponsor ID
- (META-MORE) / 2021-7267
- Conditions
- Metabolic Syndrome
- Keywords
- Myocardial oxygenation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Study start
- 30 Jun 2021 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Participant | – | Diagnostic Test: Cardiac MRIParticipants with known Metabolic Syndrome (MetS) |
| Healthy Volunteers | – | Diagnostic Test: Cardiac MRINonS-moking participants with no known pre-existing conditions and who do not take any medications |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be composed of participants with known MetS, based on the identified risk factors, and healthy volunteers.
Key inclusion criteria (8 listed)
- 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)
- Age 18-80
- No known current or pre-existing significant medical problems that would affect the cardiovascular or respiratory system
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac MRIAlso: Breathing ManeuversParticipants 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. | Diagnostic test | Healthy Volunteers, Patient Participant |
Primary outcome
Global and segmental Myocardial oxygenation reserve (MORE)
Time frame: 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.
Time frame: Baseline
A linear regression will assess the relation between Breathing maneuver induced MORE and known MetS risk factors, biomarkers, and time since diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katherine Lindsay, Master (514-934-1934 ext. 37305, katherine.lindsay@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global and segmental Myocardial oxygenation reserve (MORE) (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.