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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ivabradine 7.5mg orally | patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram |
| |
| bisoprolol | patients are only pretreated with bisoprolol orally before Cardiac CT angiogram |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ivabradine 7.5mg orally | Drug | additive use to the standard medication with bisoprolol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate | number of beats per minute | intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Use of i.v. Betablocker | measured in mg metoprolol used | time from first ECG in the CT-room to start of CT scan (average of 10 minutes) |
| Radiation Dose | as calculated in mSv |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting at the radiology center for a planned coronary computer tomographic angiography
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Bisoprolol | patients are only pretreated with bisoprolol orally before Cardiac CT angiogram |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Bisoprolol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Heart Rate | number of beats per minute | Posted | Mean | Standard Deviation | beats per minute | intraoperative |
|
|
2 hours
Clinically significant bradycardia, hypotension and dizziness were checked
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assoc. Prof. Dr. Dirk von Lewinski | Medical University of Graz | 31638580684 | 316 | dirk.von-lewinski@medunigraz.at |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D000077550 | Ivabradine |
| ID | Term |
|---|---|
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| intraoperative |
| Motion Artifacts | Counted linear misalignments in the ap projection | intraoperative |
patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| heart rate | Mean | Standard Deviation | beats per minute |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Use of i.v. Betablocker | measured in mg metoprolol used | Posted | Number | participants | time from first ECG in the CT-room to start of CT scan (average of 10 minutes) |
|
|
|
| Secondary | Radiation Dose | as calculated in mSv | Posted | Mean | Standard Deviation | mSv | intraoperative |
|
|
|
| Secondary | Motion Artifacts | Counted linear misalignments in the ap projection | Posted | Mean | Standard Deviation | linear misalignments in the ap projectio | intraoperative |
|
|
|
| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
| EG001 | Bisoprolol | patients are only pretreated with bisoprolol orally before Cardiac CT angiogram | 0 | 47 | 0 | 47 | 0 | 47 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |