- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT05574140
Andningsinducerad myokard- och cerebral perfusion vid ångeststörningar (B-GLAD)
Andningsinducerad myokard- och cerebral perfusion vid ångeststörningar (B-GLAD)
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studieorter
-
-
Quebec
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Montreal, Quebec, Kanada, H4A 3L5
- Emotional Health CBT Clinic
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
The study will recruit patient participants who are identified as having Generalized Anxiety Disorder (GAD), as well as age-similar healthy volunteer participants.
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: CASE_CONTROL
- Tidsperspektiv: PROSPECTIVE
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Patient Population
Participants diagnosed with Generalized Anxiety Disorder |
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
Andra namn:
|
|
Healthy Volunteers
Participants with no pre-existing conditions and who are on no medications. |
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
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in Signal Intensity
Tidsram: Baseline
|
Change in signal intensity between the baseline signal intensity and the signal intensity at 30 seconds of breath hold |
Baseline
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2020-6298
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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