Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol

NCT ID: NCT02764970

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2016-01-31

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.

Conditions

Bradycardia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

ivabradine 7.5mg orally

patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram

Ivabradine 7.5mg orally

Intervention Type: DRUG

additive use to the standard medication with bisoprolol

bisoprolol

patients are only pretreated with bisoprolol orally before Cardiac CT angiogram

No interventions assigned to this group

Interventions

Ivabradine 7.5mg orally

additive use to the standard medication with bisoprolol

Intervention Type: DRUG

Other Intervention Names

ivabradine is marketed as Procoralan

Eligibility Criteria

Inclusion Criteria

• all comer study

Exclusion Criteria

• none

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

26-130 ex 13/14

Identifier Type: -

Identifier Source: org_study_id