Ivabradine versus metoprolol for heart rate reduction before coronary computed tomography angiography: a randomised trial
| ISRCTN | ISRCTN74875961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN74875961 |
| Secondary identifying numbers | N/A |
- Submission date
- 21/09/2009
- Registration date
- 01/10/2009
- Last edited
- 07/09/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philipp Pichler
Scientific
Scientific
Waehringer Guertel 18-20
Vienna
1090
Austria
Study information
| Study design | Interventional single centre single-blind randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Oral premedication with ivabradine versus metoprolol for heart rate reduction before coronary computed tomography angiography: a randomised trial |
| Study objectives | 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(s) | Ethics Committee of the Privatklinik Josefstadt approved on the 18th January 2007 (ref: 002/2007) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ivabradine, metoprolol |
| Primary outcome measure | Heart rate reduction 60 - 180 minutes after medication |
| Secondary outcome measures | Systolic blood pressure before versus after medication |
| Overall study start date | 01/03/2007 |
| Completion date | 31/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 120 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 31/05/2008 |
Locations
Countries of recruitment
- Austria
Study participating centre
Waehringer Guertel 18-20
Vienna
1090
Austria
1090
Austria
Sponsor information
Medical University of Vienna (Austria)
University/education
University/education
Spitalgasse 23
Vienna
1090
Austria
| Website | http://www.meduniwien.ac.at |
|---|---|
"ROR" |
https://ror.org/05n3x4p02 |
Funders
Funder type
University/education
Medical University of Vienna (Austria)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
