An observational study in Bradycardia, sponsored by Medical University of Graz. Completed. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-19.
Sponsored by Medical University of Graz · Observational
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.
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.
306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.
This study's enrollment of 112 is below the median of 257 across 129 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Medical University of Graz is the lead sponsor of 459 studies on the registry; 98 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting at the radiology center for a planned coronary computer tomographic angiography
Exclusion Criteria:
patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram
Drug: Ivabradine 7.5mg orally
patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
additive use to the standard medication with bisoprolol
Also known as: ivabradine is marketed as Procoralan
Heart Rate
number of beats per minute
Time frame: intraoperative
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)
Radiation Dose
as calculated in mSv
Time frame: intraoperative
Motion Artifacts
Counted linear misalignments in the ap projection
Time frame: intraoperative
| Milestone | Ivabradine 7.5mg Orally | Bisoprolol |
|---|---|---|
| Started | 65 | 47 |
| Completed | 65 | 47 |
| Not completed | 0 | 0 |
number of beats per minute
| beats per minute | Ivabradine 7.5mg Orally | Bisoprolol |
|---|---|---|
| Heart Rate | 65.1 ± 9.8 | 62.7 ± 9.1 |
measured in mg metoprolol used
| participants | Ivabradine 7.5mg Orally | Bisoprolol |
|---|---|---|
| Number of Participants With Use of i.v. Betablocker | 19 | 17 |
as calculated in mSv
| mSv | Ivabradine 7.5mg Orally | Bisoprolol |
|---|---|---|
| Radiation Dose | 12.9 ± 3.4 | 13.2 ± 3.6 |
Counted linear misalignments in the ap projection
| linear misalignments in the ap projectio | Ivabradine 7.5mg Orally | Bisoprolol |
|---|---|---|
| Motion Artifacts | 5 ± 3.2 | 3.5 ± 4.4 |
Collected over 2 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ivabradine 7.5mg Orally | 0/65 (0%) | 0/65 (0%) | 0/65 (0%) |
| Bisoprolol | 0/47 (0%) | 0/47 (0%) | 0/47 (0%) |
| Age, Categorical(Participants) | Ivabradine 7.5mg Orally | Bisoprolol | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 40 | 22 | 62 |
| >=65 years | 25 | 25 | 50 |
| Age, Continuous(years) | Ivabradine 7.5mg Orally | Bisoprolol | Total |
|---|---|---|---|
| Mean | 60 ± 11 | 63 ± 10 | 61 ± 11 |
| Sex: Female, Male(Participants) | Ivabradine 7.5mg Orally | Bisoprolol | Total |
|---|---|---|---|
| Female | 26 | 23 | 49 |
| Male | 39 | 24 | 63 |
| Race and Ethnicity Not Collected(Participants) | Ivabradine 7.5mg Orally | Bisoprolol | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Ivabradine 7.5mg Orally | Bisoprolol | Total |
|---|---|---|---|
| Austria | 65 | 47 | 112 |
| heart rate(beats per minute) | Ivabradine 7.5mg Orally | Bisoprolol | Total |
|---|---|---|---|
| Mean | 84.1 ± 6.7 | 80.7 ± 5.1 | 82.8 ± 5.0 |
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Medical University of Graz