Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol

Bradycardia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02764970
• Other study ID #: 26-130 ex 13/14
• Status: Completed
• First received: March 15, 2016
• Last updated: August 24, 2017
• Start date: February 2015
• Est. completion date: January 2016

Study information

• Verified date: August 2017
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• all comer study

Exclusion Criteria:

Related Conditions & MeSH terms

• Bradycardia

Intervention

Drug:
• Ivabradine 7.5mg orally
additive use to the standard medication with bisoprolol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart Rate	number of beats per minute	intraoperative
Secondary	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)
Secondary	Radiation Dose	as calculated in mSv	intraoperative
Secondary	Motion Artifacts	Counted linear misalignments in the ap projection	intraoperative