BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders

Recruiting

• Conditions: Generalized Anxiety Disorder; Oxygenation Sensitive CMR
• Interventions: Diagnostic Test: Cardiac MRI

• Registration Number: NCT05574140
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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.

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 Timeline

• Study Start: 2022-07-15
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Status Verified: 2024-04
• Last Update Submitted: 2024-10-22
• Last Update Posted: 2024-10-24
• Primary Completion: 2025-03-15
• Study Completion: 2025-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Cardiac MRI	Participants with no pre-existing conditions and who are on no medications.
Patient Population	Cardiac MRI	Participants diagnosed with Generalized Anxiety Disorder

Primary Outcome Measures

Name	Time	Method
Change in Signal Intensity	Baseline	Change in signal intensity between the baseline signal intensity and the signal intensity at 30 seconds of breath hold

Trial Locations

Locations (1)

Emotional Health CBT Clinic; 🇨🇦 Montréal, Quebec, Canada