Trial Outcomes & Findings for Heart Rate Reducing Therapy in Cardiac CT Using Ivabradine and Bisoprolol (NCT NCT02764970)

NCT ID: NCT02764970

Last Updated: 2018-03-19

Results Overview

number of beats per minute

• Recruitment status: COMPLETED
• Target enrollment: 112 participants
• Primary outcome timeframe: intraoperative
• Results posted on: 2018-03-19

Participant Flow

Participant milestones

Measure	Ivabradine 7.5mg Orally patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol	Bisoprolol patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
Overall Study STARTED	65	47
Overall Study COMPLETED	65	47
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Ivabradine 7.5mg Orally n=65 Participants patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol	Bisoprolol n=47 Participants patients are only pretreated with bisoprolol orally before Cardiac CT angiogram	Total n=112 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=65 Participants	0 Participants n=47 Participants	0 Participants n=112 Participants
Age, Categorical Between 18 and 65 years	40 Participants n=65 Participants	22 Participants n=47 Participants	62 Participants n=112 Participants
Age, Categorical >=65 years	25 Participants n=65 Participants	25 Participants n=47 Participants	50 Participants n=112 Participants
Age, Continuous	60 years STANDARD_DEVIATION 11 • n=65 Participants	63 years STANDARD_DEVIATION 10 • n=47 Participants	61 years STANDARD_DEVIATION 11 • n=112 Participants
Sex: Female, Male Female	26 Participants n=65 Participants	23 Participants n=47 Participants	49 Participants n=112 Participants
Sex: Female, Male Male	39 Participants n=65 Participants	24 Participants n=47 Participants	63 Participants n=112 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Austria	65 participants n=65 Participants	47 participants n=47 Participants	112 participants n=112 Participants
heart rate	84.1 beats per minute STANDARD_DEVIATION 6.7 • n=65 Participants	80.7 beats per minute STANDARD_DEVIATION 5.1 • n=47 Participants	82.8 beats per minute STANDARD_DEVIATION 5.0 • n=112 Participants

PRIMARY outcome

Timeframe: intraoperative

number of beats per minute

Outcome measures

Measure	Ivabradine 7.5mg Orally n=65 Participants patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol	Bisoprolol n=47 Participants patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
Heart Rate	65.1 beats per minute Standard Deviation 9.8	62.7 beats per minute Standard Deviation 9.1

SECONDARY outcome

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

measured in mg metoprolol used

Outcome measures

Measure	Ivabradine 7.5mg Orally n=65 Participants patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol	Bisoprolol n=47 Participants patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
Number of Participants With Use of i.v. Betablocker	19 participants	17 participants

SECONDARY outcome

Timeframe: intraoperative

as calculated in mSv

Outcome measures

Measure	Ivabradine 7.5mg Orally n=65 Participants patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol	Bisoprolol n=47 Participants patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
Radiation Dose	12.9 mSv Standard Deviation 3.4	13.2 mSv Standard Deviation 3.6

SECONDARY outcome

Timeframe: intraoperative

Counted linear misalignments in the ap projection

Outcome measures

Measure	Ivabradine 7.5mg Orally n=65 Participants patients are pretreated with ivabradine and bisoprolol orally before Cardiac CT angiogram Ivabradine 7.5mg orally: additive use to the standard medication with bisoprolol	Bisoprolol n=47 Participants patients are only pretreated with bisoprolol orally before Cardiac CT angiogram
Motion Artifacts	5 linear misalignments in the ap projectio Standard Deviation 3.2	3.5 linear misalignments in the ap projectio Standard Deviation 4.4

Adverse Events

Ivabradine 7.5mg Orally

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Bisoprolol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Assoc. Prof. Dr. Dirk von Lewinski

Medical University of Graz

Phone: 31638580684

Email: dirk.von-lewinski@medunigraz.at

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place