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

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)

Overall Status

Recruiting

CT.gov ID

NCT05574140

Collaborator

(none)

Enrollment

Location

25.6

Anticipated Duration (Months)

3.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Generalized Anxiety Disorder Oxygenation Sensitive CMR	Diagnostic Test: Cardiac MRI

Detailed Description

We will prospectively analyze OS-CMR data from patients with a generalized anxiety disorder from one site. We will investigate how anxiety disorder affects the OS-CMR data. In a follow-up MRI scan, we 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 Design

Study Type:

Observational

Anticipated Enrollment :

84 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Mar 1, 2023

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	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

Arm

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

Other Names:

Breathing Maneuvers

Outcome Measures

Primary Outcome Measures

Change in Signal Intensity [Baseline]
Change in signal intensity between the baseline signal intensity and the signal intensity at 30 seconds of breath hold

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emotional Health CBT Clinic	Montréal	Quebec	Canada	H4A 3L5

Sponsors and Collaborators

McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Matthias Friedrich, Principal Investigator, McGill University Health Centre/Research Institute of the McGill University Health Centre

ClinicalTrials.gov Identifier:

NCT05574140

Other Study ID Numbers:

2020-6298

First Posted:

Oct 10, 2022

Last Update Posted:

Oct 10, 2022

Last Verified:

Oct 1, 2022

Additional relevant MeSH terms:

Anxiety Disorders

Study Results

No Results Posted as of Oct 10, 2022