NCT02764970

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2015

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
1.9 years until next milestone

Results Posted

Study results publicly available

March 19, 2018

Completed
Last Updated

March 19, 2018

Status Verified

August 1, 2017

Enrollment Period

7 months

First QC Date

March 15, 2016

Results QC Date

February 17, 2017

Last Update Submit

August 24, 2017

Conditions

Bradycardia

Outcome Measures

Primary Outcomes (1)

  • Heart Rate

    number of beats per minute

    intraoperative

Secondary Outcomes (3)

  • Number of Participants With Use of i.v. Betablocker

    time from first ECG in the CT-room to start of CT scan (average of 10 minutes)

  • Radiation Dose

    intraoperative

  • Motion Artifacts

    intraoperative

Study Arms (2)

ivabradine 7.5mg orally

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

Drug: Ivabradine 7.5mg orally

bisoprolol

patients are only pretreated with bisoprolol orally before Cardiac CT angiogram

Interventions

Ivabradine 7.5mg orallyDRUG

additive use to the standard medication with bisoprolol

Also known as: ivabradine is marketed as Procoralan
ivabradine 7.5mg orally

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • all comer study

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Bradycardia

Interventions

Ivabradine

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Assoc. Prof. Dr. Dirk von Lewinski
Organization
Medical University of Graz
dirk.von-lewinski@medunigraz.at
31638580684

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 15, 2016

First Posted

May 6, 2016

Study Start

February 1, 2015

Primary Completion

September 1, 2015

Study Completion

January 1, 2016

Last Updated

March 19, 2018

Results First Posted

March 19, 2018

Record last verified: 2017-08

Data Sharing

IPD Sharing
Will not share