Condition category
Circulatory System
Date applied
21/09/2009
Date assigned
01/10/2009
Last edited
07/09/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philipp Pichler

ORCID ID

Contact details

Waehringer Guertel 18-20
Vienna
1090
Austria

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Oral premedication with ivabradine versus metoprolol for heart rate reduction before coronary computed tomography angiography: a randomised trial

Acronym

Study hypothesis

1. Oral premedication with either ivabradine or metoprolol provides sufficient heart rate control in patients before coronary computed tomography angiography
2. Ivabradine leads to less blood pressure drop compared to metoprolol

Ethics approval

Ethics Committee of the Privatklinik Josefstadt approved on the 18th January 2007 (ref: 002/2007)

Study design

Interventional single centre single-blind randomised study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Coronary artery disease

Intervention

Oral medication with 15 mg ivabradine versus 50 mg metoprolol before coronary computed tomography angiography. Drugs were administered once with a one-time follow-up 1 - 3 hours after intervention.

Intervention type

Drug

Phase

Phase IV

Drug names

Ivabradine, metoprolol

Primary outcome measures

Heart rate reduction 60 - 180 minutes after medication

Secondary outcome measures

Systolic blood pressure before versus after medication

Overall trial start date

01/03/2007

Overall trial end date

31/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Sinus rhythm
2. Heart rate greater than or equal to 60 bpm
3. Systolic blood pressure greater than or equal to 100 mmHg
4. Aged greater than or equal to 19 years irrespective of gender

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

120

Participant exclusion criteria

1. Known allergy to iodinated contrast media
2. Impaired renal function (creatinine serum level greater than 1.5 mg/dl)
3. Thyroid disorder
4. Unstable clinical condition
5. Frequent premature heartbeats
6. Sick-sinus-syndrome
7. Sinoatrial block
8. Second or third degree AV-block
9. Previous pacemaker implantation

Recruitment start date

01/03/2007

Recruitment end date

31/05/2008

Locations

Countries of recruitment

Austria

Trial participating centre

Waehringer Guertel 18-20
Vienna
1090
Austria

Sponsor information

Organisation

Medical University of Vienna (Austria)

Sponsor details

Spitalgasse 23
Vienna
1090
Austria

Sponsor type

University/education

Website

http://www.meduniwien.ac.at

Funders

Funder type

University/education

Funder name

Medical University of Vienna (Austria)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes