Bradycardia
Conditions
Brief summary
Out-patients scheduled for coronary computer tomographic angiography (CCTA) were screened regarding their baseline heart rate. If heart rate was \> 75, patients were pretreated with 10mg bisoprolol (group 1) or 10mg bisoprolol plus 7.5mg ivabradine (group 2) to reduce heart rate one our before CCTA was performed. Heart rate, additional use of i.v. bradycardic agents, motion artefacts, radiation dose and drug tolerance was monitored.
Detailed description
Aim of the study is to evaluate if ivabradine, an inhibitor of the funny channel (If), in addition to bisoprolol is effective in lowering heart rate before coronary computer tomographic angiography (CCTA) if administered orally one hour before the scan. Out-patients of a single radiology center are included in this retrospective analysis. All patients are referred to an ambulant CCTA. All scans are performed with a Siemens Somatom Sensation Cardiac 64 Computer Tomograph and analyzed with Siemens Syngo Plaza software. Patients with an initial heart rate of ≥ 75 bpm are either pretreated with bisoprolol 10mg p.o. alone (group 1) or a combination of bisoprolol 10mg and ivabradine 7.5mg p.o. (group 2) one hour before the CT scan. The change in treatment from bisoprolol only to the combination of bisoprolol and ivabradine was introduced as a change in standard treatment independent of the study. The study was only plannend and performed as a retrospective analysis after the last patient included into the analysis was already treated. Additional betablocker is administered intravenously right before the scan if heart rate remains elevated. The hypothesis is that the addition of ivabradine to bisoprolol results in a pronounced heart rate reduction. This heart rate reduction will lead to a reduced need of i.v. bradicardic drug use, a reduction in motion artifacts and a reduced radiation dose to to a higher rate of flash sequences.
Interventions
DRUGIvabradine 7.5mg orally
additive use to the standard medication with bisoprolol
Sponsors
Medical University of Graz
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* all comer study
Exclusion criteria
* none
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | intraoperative | number of beats per minute |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Use of i.v. Betablocker | time from first ECG in the CT-room to start of CT scan (average of 10 minutes) | measured in mg metoprolol used |
| Radiation Dose | intraoperative | as calculated in mSv |
| Motion Artifacts | intraoperative | Counted linear misalignments in the ap projection |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ivabradine 7.5mg Orally patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram
Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol | 65 |
| Bisoprolol patients are only pretreated with bisoprolol orally before Cardiac CT angiogram | 47 |
| Total | 112 |
Baseline characteristics
| Characteristic | Ivabradine 7.5mg Orally | Bisoprolol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 25 Participants | 25 Participants | 50 Participants |
| Age, Categorical Between 18 and 65 years | 40 Participants | 22 Participants | 62 Participants |
| Age, Continuous | 60 years STANDARD_DEVIATION 11 | 63 years STANDARD_DEVIATION 10 | 61 years STANDARD_DEVIATION 11 |
| heart rate | 84.1 beats per minute STANDARD_DEVIATION 6.7 | 80.7 beats per minute STANDARD_DEVIATION 5.1 | 82.8 beats per minute STANDARD_DEVIATION 5 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Austria | 65 participants | 47 participants | 112 participants |
| Sex: Female, Male Female | 26 Participants | 23 Participants | 49 Participants |
| Sex: Female, Male Male | 39 Participants | 24 Participants | 63 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 65 | 0 / 47 |
| other Total, other adverse events | 0 / 65 | 0 / 47 |
| serious Total, serious adverse events | 0 / 65 | 0 / 47 |
Outcome results
Primary
Heart Rate
number of beats per minute
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ivabradine 7.5mg Orally | Heart Rate | 65.1 beats per minute | Standard Deviation 9.8 |
| Bisoprolol | Heart Rate | 62.7 beats per minute | Standard Deviation 9.1 |
Secondary
Motion Artifacts
Counted linear misalignments in the ap projection
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ivabradine 7.5mg Orally | Motion Artifacts | 5 linear misalignments in the ap projectio | Standard Deviation 3.2 |
| Bisoprolol | Motion Artifacts | 3.5 linear misalignments in the ap projectio | Standard Deviation 4.4 |
Secondary
Number of Participants With Use of i.v. Betablocker
measured in mg metoprolol used
Time frame: time from first ECG in the CT-room to start of CT scan (average of 10 minutes)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Ivabradine 7.5mg Orally | Number of Participants With Use of i.v. Betablocker | 19 participants |
| Bisoprolol | Number of Participants With Use of i.v. Betablocker | 17 participants |
Secondary
Radiation Dose
as calculated in mSv
Time frame: intraoperative
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ivabradine 7.5mg Orally | Radiation Dose | 12.9 mSv | Standard Deviation 3.4 |
| Bisoprolol | Radiation Dose | 13.2 mSv | Standard Deviation 3.6 |