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RecruitingNCT05574140B-GLADUpdated Oct 24, 2024

BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders

An observational study in Generalized Anxiety Disorder and Oxygenation Sensitive CMR, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Recruiting at 1 site in Canada. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Observational

From the registry’s dates

  • Primary completion was expected by Mar 2025, 1 year 6 months ago, but the record still lists the study as recruiting.
  • Started Jul 2022; still recruiting 4 years 2 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
84
Ages
18 Years to 55 Years
Sex
All
01

Study summary

This study aims to view variations in MRI measurements of the heart and the brain in people with anxiety versus healthy volunteers. The MRI measurements used will be Oxygenation-Sensitive Cardiac MRI (OS-CMR), a recent type of MRI which is safe, fast, and non-invasive.

Read the detailed description

The investigators will prospectively analyze OS-CMR data from patients with a generalized anxiety disorder from one site. The investigators will observe how an anxiety disorder affects the OS-CMR data. In a follow-up MRI scan, the investigators will look at the OS-CMR of a subgroup who have anxiety disorder and are also undertaking cognitive behavioural therapy to asses how and if this therapy affects the OS-CMR data.

02

Conditions studied

  • Generalized Anxiety Disorder
  • Oxygenation Sensitive CMR

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03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,388 are open to participants now.

This study's planned enrollment of 84 is below the median of 150 across 606 observational studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 414 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The study will recruit patient participants who are identified as having Generalized Anxiety Disorder (GAD), as well as age-similar healthy volunteer participants.

Inclusion criteria

Patient population:

Age 18-55,

  • Confirmation of an anxiety disorder as identified by the PSWQ,
  • No known, current or history, of significant medical conditions that may affect or directly involve the neurological, cardiovascular or respiratory system (except anxiety and depression)
  • Non-smoker

Healthy Volunteers:

  • Age 18-55
  • No known, current or history, of significant medical conditions that may affect or directly involve the neurological, cardiovascular or respiratory system
  • Non-smoker

Exclusion criteria

Exclusion Criteria:

  • General MRI contraindications: pacemakers, defibrillating wires, implanted defibrillators, intracranial aneurysm clips, metallic foreign bodies in the eyes, pregnancy
  • History of significant neurological disease or illness that is not anxiety (e.g. Dementia, stroke)
  • Hemodynamically unstable conditions
  • Significant or uncontrolled arrhythmias
  • Severe pulmonary disease
  • Recent (\<90 days) myocardial infarction
  • Recent (\<90 days) surgery or coronary intervention
  • Consumption of caffeine (caffeinated beverages, coffee, tea, cocoa, chocolate) within 12h of the exam
  • Use of benzodiazepines or other short-acting anxiety medications (\<1 day)
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
84 participants (estimated)
Patient registry
No

Groups and cohorts

  • Patient Population

    Participants diagnosed with Generalized Anxiety Disorder

    Diagnostic Test: Cardiac MRI

  • Healthy Volunteers

    Participants with no pre-existing conditions and who are on no medications.

    Diagnostic Test: Cardiac MRI

Interventions

  • Diagnostic testCardiac MRI

    The 4-minute breathing maneuver comprised of 2 minutes of normal breathing and 1-min hyperventilation (rate of 30 breaths per minute) followed by a maximal breath-hold. This technique is used in Oxygenation Sensitive CMR, a type of MRI, and will induce a vasoactive response visible in cardiac and cerebral MRI images

    Also known as: Breathing Maneuvers

06

What researchers measure

Primary outcomes

  1. Change in Signal Intensity

    Change in signal intensity between the baseline signal intensity and the signal intensity at 30 seconds of breath hold

    Time frame: Baseline

07

Study locations

1 of 1 sites recruiting
  • Emotional Health CBT Clinic
    Montréal, Quebec H4A 3L5, Canada
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05574140
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Responsible party
Matthias Friedrich (Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre) — Principal investigator
First posted
Oct 10, 2022
Start date
Jul 15, 2022
Primary completion
Mar 15, 2025 (estimated)
Completion
Sep 15, 2025 (estimated)
Last update
Oct 24, 2024

Study contacts

Mayssa Moukarzel
Contact
mayssa.moukarzel@mail.mcgill.ca
(514) 5530-7385
Elizabeth Konidis, Master
Contact
elisavet.konidis@muhc.mcgill.ca
514-934-1934 ext. 37305

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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