BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders

NCT05574140 | Recruiting DMC

• 1 other identifier: 2020-6298
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder; Oxygenation Sensitive CMR

Outcome Measures

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

  Baseline

Study Arms (2)

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

Cardiac MRI DIAGNOSTIC_TEST

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

Healthy Volunteers; Patient Population

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Emotional Health CBT Clinic

Montreal, Quebec, H4A 3L5, Canada

RECRUITING

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Central Study Contacts

Mayssa Moukarzel

CONTACT

(514) 5530-7385; mayssa.moukarzel@mail.mcgill.ca

Elizabeth Konidis, Master

CONTACT

514-934-1934; elisavet.konidis@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 6, 2022
• First Posted: October 10, 2022
• Study Start: July 15, 2022
• Primary Completion: March 15, 2025
• Study Completion: September 15, 2025
• Last Updated: October 24, 2024

Record last verified: 2024-04

Locations

CA (1)