BradycardiaNCT02764970
Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol
An observational study of Bradycardia, run by Medical University of Graz.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bradycardia
- What is being tested?
- Ivabradine 7.5mg orally
- Type of treatment
- Pill or oral medicine
- How many people
- 112 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jan 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presenting at the radiology center for a planned coronary computer tomographic angiography
Who may be able to join
- all comer study
Who cannot join
- none
About this study
Official title: 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.
Read the 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
- Being tested
- Ivabradine 7.5mg orally
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ivabradine 7.5mg orallyDrug
Also called ivabradine is marketed as Procoralan
additive use to the standard medication with bisoprolol
| Study group | Role | What they receive |
|---|---|---|
| ivabradine 7.5mg orally | patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram Receives: Drug: Ivabradine 7.5mg orally | |
| bisoprolol | patients are only pretreated with bisoprolol orally before Cardiac CT angiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate
number of beats per minute
Measured: intraoperative
Secondary outcomes (3)
Number of Participants With Use of i.v. Betablocker
measured in mg metoprolol used
Measured: time from first ECG in the CT-room to start of CT scan (average of 10 minutes)
Radiation Dose
as calculated in mSv
Measured: intraoperative
Motion Artifacts
Counted linear misalignments in the ap projection
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02764970
- Sponsor's protocol ID
- 26-130 ex 13/14
- Status last verified
- Aug 2017
- First submitted
- 15 Mar 2016
- Last updated
- 19 Mar 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heart Rate Reducing Therapy With Ivabradine and Bisoprolol Before Coronary Computer Tomographic Angiography in Ambulant Patients
- ClinicalTrials.gov ID
- NCT02764970
- Acronym / sponsor ID
- 26-130 ex 13/14
- Conditions
- Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 6 May 2016 (estimated)
- Results
- Posted 19 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ivabradine 7.5mg orally | – | Drug: Ivabradine 7.5mg orallypatients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram |
| bisoprolol | – | –patients are only pretreated with bisoprolol orally before Cardiac CT angiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting at the radiology center for a planned coronary computer tomographic angiography
Key inclusion criteria (1 listed)
- all comer study
Key exclusion criteria (1 listed)
- none
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivabradine 7.5mg orallyAlso: ivabradine is marketed as Procoralanadditive use to the standard medication with bisoprolol | Drug | ivabradine 7.5mg orally |
Primary outcome
Heart Rate
Time frame: intraoperative
number of beats per minute
3 secondary outcomes
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)
Radiation Dose
Time frame: intraoperative
Motion Artifacts
Time frame: intraoperative
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia, run by Medical University of Graz.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate (time frame: intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2018.