Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol

August 24, 2017 updated by: Medical University of Graz

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients presenting at the radiology center for a planned coronary computer tomographic angiography

Description

Inclusion Criteria:

  • all comer study

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ivabradine 7.5mg orally
patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram
Drug: Ivabradine 7.5mg orally
additive use to the standard medication with bisoprolol
Other Names:
  • ivabradine is marketed as Procoralan
bisoprolol
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
Time Frame: intraoperative
number of beats per minute
intraoperative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Use of i.v. Betablocker
Time Frame: time from first ECG in the CT-room to start of CT scan (average of 10 minutes)
measured in mg metoprolol used
time from first ECG in the CT-room to start of CT scan (average of 10 minutes)
Radiation Dose
Time Frame: intraoperative
as calculated in mSv
intraoperative
Motion Artifacts
Time Frame: intraoperative
Counted linear misalignments in the ap projection
intraoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

March 15, 2016

First Submitted That Met QC Criteria

May 4, 2016

First Posted (Estimate)

May 6, 2016

Study Record Updates

Last Update Posted (Actual)

March 19, 2018

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-130 ex 13/14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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