BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders

Generalized Anxiety Disorder Clinical Trial

— B-GLAD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05574140
• Other study ID #: 2020-6298
• Status: Recruiting
• Start date: July 15, 2022
• Est. completion date: September 15, 2025

Study information

• Verified date: April 2024
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: Mayssa Moukarzel
• Phone: (514) 5530-7385
• Email: mayssa.moukarzel[@]mail.mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: September 15, 2025
• Est. primary completion date: March 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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

Locations

Country	Name	City	State
Canada	Emotional Health CBT Clinic	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	Change in Signal Intensity	Change in signal intensity between the baseline signal intensity and the signal intensity at 30 seconds of breath hold	Baseline