BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders

NCT ID: NCT05574140

Last Updated: 2024-10-24

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 84 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-15
• Study Completion Date: 2025-09-15

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.

Conditions

Generalized Anxiety Disorder; Oxygenation Sensitive CMR

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient Population

Participants diagnosed with Generalized Anxiety Disorder

Cardiac MRI

Intervention Type: 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

Healthy Volunteers

Participants with no pre-existing conditions and who are on no medications.

Cardiac MRI

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Breathing Maneuvers

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Matthias Friedrich

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Emotional Health CBT Clinic

Montreal, Quebec, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mayssa Moukarzel

Role: CONTACT

mayssa.moukarzel@mail.mcgill.ca

(514) 5530-7385

Elizabeth Konidis, Master

Role: CONTACT

elisavet.konidis@muhc.mcgill.ca

514-934-1934 ext. 37305

Facility Contacts

Ruby Clark

Role: primary

info@cbtclinic.ca

5144857772

Mayssa Moukarzel

Role: backup

Other Identifiers

2020-6298

Identifier Type: -

Identifier Source: org_study_id