- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05574140
Puste-indusert myokard og cerebral perfusjon ved angstlidelser (B-GLAD)
Pusteindusert myokard- og cerebral perfusjon ved angstlidelser (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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiesteder
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Quebec
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Montreal, Quebec, Canada, H4A 3L5
- Emotional Health CBT Clinic
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
The study will recruit patient participants who are identified as having Generalized Anxiety Disorder (GAD), as well as age-similar healthy volunteer participants.
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: CASE_CONTROL
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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
Andre navn:
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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
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Signal Intensity
Tidsramme: Baseline
|
Change in signal intensity between the baseline signal intensity and the signal intensity at 30 seconds of breath hold |
Baseline
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Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2020-6298
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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