Magnetic Resonance Imaging Clinical Trial
— MRIOfficial title:
Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.
Verified date | August 2020 |
Source | Masaryk Hospital Krajská zdravotní a.s. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare the changes in heart function, induced after sedation with midazolam or
dexmedetomidine, using cardiac magnetic resonance imaging (MRI).
This study is a randomized unmasked study, in which participant will be allocated by the
envelop method into the dexmedetomidine (DEX) group or into the midazolam (MID) group.
Status | Completed |
Enrollment | 30 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients who were admitted due to chest pain, in whom acute coronary syndrome, pulmonary embolism and acute aortic syndrome were ruled out - Age =18 and = 65 years - No contraindication to provide cardiac MRI - No known allergy to Midazolam or Dexmedetomidine - Signed informed consent - No history of heart, hepatic, renal or respiratory failure Exclusion Criteria: - Atrial fibrilation - Claustrophobia - Heart Failure - Renal Failure - Hepatic disease - Respiratory insufficiency - Fertility and lactation - Patients who cannot cooperate or refuse to sign the consent. |
Country | Name | City | State |
---|---|---|---|
Czechia | Department of Cardiology, Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic. | Ústí Nad Labem |
Lead Sponsor | Collaborator |
---|---|
Masaryk Hospital Krajská zdravotní a.s. |
Czechia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in cardiac output following sedation administration | Using cardiac MRI stroke volume (measured in mL) of both heart ventricles will be registered prior and after sedation administration. | 5 minutes following sedation administration. | |
Primary | Changes in diastolic heart function following sedation administration | Using cardiac MRI maximum flow velocity through the mitral valve (measured in mL/s) during early and late diastole will be measured prior and after sedation administration. | 5 minutes following sedation administration. |
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