Recruiting

Observational Study

Sponsor:

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

Code:

NCT05574140

Conditions

Generalized Anxiety Disorder

Oxygenation Sensitive CMR

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Cardiac MRI

Study Details

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

Study ID

NCT05574140

Start date

Jul 15, 2022

Status verified date

Apr, 2024

Completion date

Sep 15, 2025

Anticipated

Primary completion date

Mar 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

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

Enrollment

84 participants

Anticipated

Interventions and Outcome Measures

Arms

Patient Population

Participants diagnosed with Generalized Anxiety Disorder

Healthy Volunteers

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

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

Primary outcome measure

  • Change in Signal Intensity [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Mayssa Moukarzel

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

Elizabeth Konidis, Master

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

Locations

Emotional Health CBT Clinic

Recruiting

Montréal, Quebec, Canada, H4A 3L5

Contacts

Ruby Clark

5144857772info@cbtclinic.ca

More Information

Sponsor

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

Last update posted

Oct 24, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University Health Centre/Research Institute of the McGill University Health Centre on 2024-10-24.