BreathinG-induced Myocardial and Cerebral Perfusion in An... | NCT05574140

Studies
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders

NCT05574140

Sponsor

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

Status

Unknown status

Last Update Posted

Oct 24, 2024Actual

Enrollment

84Estimated

Phase

Not provided

Conditions

Generalized Anxiety Disorder
Oxygenation Sensitive CMR

Interventions

Cardiac MRI

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2022Actual

Primary Completion Date

Mar 15, 2025Estimated

Completion Date

Sep 15, 2025Estimated

First Submitted Date

Oct 6, 2022

First Submission Date that Met QC Criteria

Oct 6, 2022

First Posted Date

Oct 10, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2024

Last Update Posted Date

Oct 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

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

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

84Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Signal Intensity	Change in signal intensity between the baseline signal intensity and the signal intensity at 30 seconds of breath hold	Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

55 Years

Standard Ages

Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mayssa Moukarzel	Contact	(514) 5530-7385		mayssa.moukarzel@mail.mcgill.ca
Elizabeth Konidis, Master	Contact	514-934-1934	37305	elisavet.konidis@muhc.mcgill.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Emotional Health CBT Clinic	Recruiting	Montreal	Quebec	H4A 3L5	Canada

ID	Term
D001008	Anxiety Disorders
D001523	Mental Disorders