Cardiac FunctionPhase 4MRINCT04529187
Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.
A Phase 4 study testing Midazolam and Dexmedetomidine in people with Cardiac Function and Sedation, run by Masaryk Hospital Krajská zdravotní a.s. at 1 site in Czechia.
Trial summary
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)… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Function, Sedation, Magnetic Resonance Imaging
- What is being tested?
- Midazolam and Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2018to 31 Dec 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Atrial fibrilation
- Claustrophobia
- Heart Failure
- Renal Failure
- Hepatic disease
- Respiratory insufficiency
- Fertility and lactation
- Patients who cannot cooperate or refuse to sign the consent.
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Department of Cardiology, Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.
Ústí nad Labem, 40011
About this study
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.
Read the detailed description
The study will test the hypothesis that the use of dexmedetomidine leads to less negative impact on ventricular function compared to midazolam.
The study will include patients who will meet the inclusion criteria. A previous, yet unpublished, pilot study assured that a number of 15 participants in each arm is sufficient to detect statistical significant results with a statistical power of ≥ 80%. After signing the informed consent, a one-session cardiac MRI will be performed in each fasting participant before and after sedation administration (see arms and intervention). The following parameters will be recorded: end diastolic and end systolic volume, left and right ventricle stroke volume and flow velocity through the mitral valve during early and late diastole. A monitor will record values of mean blood pressure, pulse and blood oxygen saturation in 5-minute intervals.
The acquired data will be transferred to an offline workstation for postprocessing and quantification. In participants we will calculate left ventricular volumes using the well-known Simpson's formula by segmenting of endocardial borders on end-diastolic and end-systolic frames on every slice through the left ventricle.
The quantitative flow measurement will be performed using phase contrast quantification flow mapping.
Statistical analyses will be performed using STATISTICA software (data analysis software system, version 13 TIBCO Software Inc). All values will be presented as average ± standard deviation. Analysis of variance for repeated measures with post hoc Fisher's LSD test will be used for statistical testing of significant differences in each group and between the groups before and after sedation, respectively. Significance level will be accepted at α<0.05.
The participants will be monitored during sedation administration and 6 hours following sedation cessation to avoid complications that could be associated with sedation administration such as hypotension or rhythm disturbances.
- Conditions
- Cardiac Function, Sedation, Magnetic Resonance Imaging
- Being tested
- Midazolam, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MidazolamDrug
Also called Dormicum® (Roche, F. Hoffmann-La Roche Ltd Basel, Switzerland)
To monitor the changes in heart function induced after midazolam sedation using cardiac MRI.
DexmedetomidineDrug
Also called Dexdor® (Orion Corporation, Nasdaq OMX Helsinki: ORNAV and ORNBV, Finland)
To monitor the changes in heart function induced after dexmedetomidine sedation using cardiac MRI.
| Study group | Role | What they receive |
|---|---|---|
| DEX group | Active comparator | Participants allocated into this arm will undergo a baseline cardiac MRI. Then a dexmedetomidine infusion in a rate of of 0.7 ug.kg-1.hr-1will be initiated. After 5 minutes of dexmedetomidine therapy a control cardiac MRI will be performed to detect changes in heart function following sedation administration. Receives: Drug: Dexmedetomidine |
| MID group | Active comparator | Participants allocated into this arm will undergo a baseline cardiac MRI. Then a single dose of midazolam (2 mg intravenously) will be given to each participant in this arm. After 5 minutes of midazolam administration a control cardiac MRI will be performed to detect changes in heart function following sedation administration. Receives: Drug: Midazolam |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 minutes following sedation administration.
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.
Measured: 5 minutes following sedation administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2020
- Study start1 Jan 2018
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk Hospital Krajská zdravotní a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nedal Omran, Masaryk Hospital Krajská zdravotní a.s.
- Investigators
- Nedal Omran, M.D, Principal investigator, Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529187
- Sponsor's protocol ID
- Masaryk Hospital
- Acronym
- MRI
- Status last verified
- Aug 2020
- First submitted
- 18 Aug 2020
- Last updated
- 27 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Midazolam and Dexmedetomidine on Heart Function - A Randomized MRI-based Study.
- ClinicalTrials.gov ID
- NCT04529187
- Acronym / sponsor ID
- MRI / Masaryk Hospital
- Conditions
- Cardiac Function, Sedation, Magnetic Resonance Imaging
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Masaryk Hospital Krajská zdravotní a.s.University, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 27 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study will test the hypothesis that the use of dexmedetomidine leads to less negative impact on ventricular function compared to midazolam.
The study will include patients who will meet the inclusion criteria. A previous, yet unpublished, pilot study assured that a number of 15 participants in each arm is sufficient to detect statistical significant results with a statistical power of ≥ 80%. After signing the informed consent, a one-session cardiac MRI will be performed in each fasting participant before and after sedation administration (see arms and intervention). The following parameters will be recorded: end diastolic and end systolic volume, left and right ventricle stroke volume and flow velocity through the mitral valve during early and late diastole. A monitor will record values of mean blood pressure, pulse and blood oxygen saturation in 5-minute intervals.
The acquired data will be transferred to an offline workstation for postprocessing and quantification. In participants we will calculate left ventricular volumes using the well-known Simpson's formula by segmenting of endocardial borders on end-diastolic and end-systolic frames on every slice through the left ventricle.
The quantitative flow measurement will be performed using phase contrast quantification flow mapping.
Statistical analyses will be performed using STATISTICA software (data analysis software system, version 13 TIBCO Software Inc). All values will be presented as average ± standard deviation. Analysis of variance for repeated measures with post hoc Fisher's LSD test will be used for statistical testing of significant differences in each group and between the groups before and after sedation, respectively. Significance level will be accepted at α<0.05.
The participants will be monitored during sedation administration and 6 hours following sedation cessation to avoid complications that could be associated with sedation administration such as hypotension or rhythm disturbances.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DEX group | Active comparator | Drug: DexmedetomidineParticipants allocated into this arm will undergo a baseline cardiac MRI. Then a dexmedetomidine infusion in a rate of of 0.7 ug.kg-1.hr-1will be initiated. After 5 minutes of dexmedetomidine therapy a control cardiac MRI will be performed to detect changes in heart function following sedation administration. |
| MID group | Active comparator | Drug: MidazolamParticipants allocated into this arm will undergo a baseline cardiac MRI. Then a single dose of midazolam (2 mg intravenously) will be given to each participant in this arm. After 5 minutes of midazolam administration a control cardiac MRI will be performed to detect changes in heart function following sedation administration. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- Atrial fibrilation
- Claustrophobia
- Heart Failure
- Renal Failure
- Hepatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MidazolamAlso: Dormicum® (Roche, F. Hoffmann-La Roche Ltd Basel, Switzerland)To monitor the changes in heart function induced after midazolam sedation using cardiac MRI. | Drug | MID group |
| DexmedetomidineAlso: Dexdor® (Orion Corporation, Nasdaq OMX Helsinki: ORNAV and ORNBV, Finland)To monitor the changes in heart function induced after dexmedetomidine sedation using cardiac MRI. | Drug | DEX group |
Primary outcome
Changes in cardiac output following sedation administration
Time frame: 5 minutes following sedation administration.
Using cardiac MRI stroke volume (measured in mL) of both heart ventricles will be registered prior and after sedation administration.
Changes in diastolic heart function following sedation administration
Time frame: 5 minutes 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nedal Omran, M.D principal investigator
Masaryk Hospital and UJEP, Usti nad Labem, Czech Republic.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Midazolam and Dexmedetomidine in people with Cardiac Function and Sedation, run by Masaryk Hospital Krajská zdravotní a.s. at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in cardiac output following sedation administration (time frame: 5 minutes following sedation administration.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2020; AzTrials last refreshed its copy on 4 Nov 2026.