Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol

Study Overview
=================
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.

Official Title
-----------------
Heart Rate Reducing Therapy With Ivabradine and Bisoprolol Before Coronary Computer Tomographic Angiography in Ambulant Patients

Conditions
-----------------
Bradycardia

Intervention / Treatment
-----------------
* Drug: Ivabradine 7.5mg orally


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all comer study Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ivabradine 7.5mg orally<br>patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram | Drug: Ivabradine 7.5mg orally<br>* additive use to the standard medication with bisoprolol<br>* Other names: ivabradine is marketed as Procoralan;|
| bisoprolol<br>patients are only pretreated with bisoprolol orally before Cardiac CT angiogram | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate | number of beats per minute | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | 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 | intraoperative | 
| Motion Artifacts | Counted linear misalignments in the ap projection | intraoperative |