BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders (B-GLAD)

BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders (B-GLAD)

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.

Study Overview

• Status: Recruiting
• Conditions: Generalized Anxiety Disorder; Oxygenation Sensitive CMR
• Intervention / Treatment: Diagnostic test: Cardiac MRI

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.

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Elizabeth Konidis, Master; Phone Number: 37305 514-934-1934; Email: elisavet.konidis@muhc.mcgill.ca
• Study Contact Backup: Name: Mayssa Moukarzel; Phone Number: (514) 5530-7385; Email: mayssa.moukarzel@mail.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H4A 3L5
      • Recruiting
      • Emotional Health CBT Clinic
      • Contact: Ruby Clark; Phone Number: 5144857772; Email: info@cbtclinic.ca
      • Contact: Mayssa Moukarzel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• 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.

Description

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:

• 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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient Population; Participants diagnosed with Generalized Anxiety Disorder	Diagnostic test: Cardiac 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; Other Names: Breathing Maneuvers
Healthy Volunteers; Participants with no pre-existing conditions and who are on no medications.	Diagnostic test: Cardiac 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; Other Names: Breathing Maneuvers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Signal Intensity	Change in signal intensity between the baseline signal intensity and the signal intensity at 30 seconds of breath hold	Baseline

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2022
• Primary Completion (Estimated): March 15, 2025
• Study Completion (Estimated): September 15, 2025

Study Registration Dates

• First Submitted: October 6, 2022
• First Submitted That Met QC Criteria: October 6, 2022
• First Posted (Actual): October 10, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 2020-6298

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No