Influence of heart rate reduction on heart injury that happens during interventional coronary procedure and stent deployment in patients with coronary disease
| ISRCTN | ISRCTN59609019 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN59609019 |
| Secondary identifying numbers | 2010/5 |
- Submission date
- 29/06/2018
- Registration date
- 06/07/2018
- Last edited
- 05/08/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
There is no data that heart rate reduction reduces periprocedural myocardial injury in patients undergoing elective percutaneous coronary intervention (angiography of coronary vessels with subsequent stent implantation in narrowed segments in order to reestablish normal blood flow through coronary vessels). Ivabradine is an established drug that reduces heart rate (HR) and subsequently alleviates symptoms of angina (heart pain due to coronary stenoses). In this study we sought to determine whether HR reduction via ivabradine attenuates or reduces the amount of myocardial injury that in small extent occurs during stent implantation.
they were eligible if heart rate was above 70/min and afterwards randomized in two groups (ivabradine group and control group)
40 patients with stable angina and resting heart rate above 70 beats per minute (bpm) were assigned to ivabradine 5 mg twice daily. The control group consisted of 40 patients with resting heart rate above 70 bpm. All patients were included 1 month before scheduled intervention. After admission troponin I levels (blood marker of myocardial damage or injury) were measured before the procedure and after 24 hours. We also collected data of any change in symptoms in both groups.
The benefit was that patients were examined more frequently; also the clinical benefit of treatment with ivabradine was previously proven and the prescription was in line with guidelines for treatment of patients with ischemic heart (coronary) disease. There were no potential additional risks for included patients.
Contact information
Scientific
Ljubljanska ulica 5
Maribor
2000
Slovenia
 ORCID ID |
0000-0002-1425-4189 |
|---|---|
| Phone | +386 (0)23212371 |
| franjo.naji@yahoo.com |
Study information
| Study design | Single-center interventional 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 contact details to request a participant information sheet |
| Scientific title | Effect of heart rate reduction on periprocedural myocardial injury and angina symptoms in elective patients with coronary disease undergoing coronary intervention |
| Study objectives | Heart rate reduction via ivabradine treatment reduces periprocedural myocardial injury and reduces symptoms in patients with stable coronary disease undergoing interventional coronary procedure. |
| Ethics approval(s) | Institutional ethics committee University Clinical center Maribor, 05/05/2010, approval Nr: 092-30/2010 |
| Health condition(s) or problem(s) studied | Ischemic heart disease with stable angina |
| Intervention | After inclusion criteria were met patients were invited to participate in study. Informed consent was obtained, and patients were instructed to attend first visit one month before planned procedure. At first visit heart rate was reassessed. Patients were asked about their usual therapy adherence and then instructed to rest for five minutes. 12-lead ECG was recorded and if eligible (heart rate > 70 bpm) patients were then randomly assigned to one of two groups. Patients were randomized so that the first patient was in group 1 and the second was in group 2 and so on. Patients in group 1 were prescribed ivabradine 5 mg twice daily on top of their standard therapy and patients in group 2 received no additional treatment. Treatment with ivabradine wasn't stopped after the study conclusion. There was no long-term follow-up or additional visits for the patients included in the protocol, patients had regular visits based on their clinical characteristics. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Ivabradine |
| Primary outcome measure | Periprocedural myocardial injury, measured using cardiac troponin I assay (Siemens Healthcare Diagnostics) from blood samples at admission (before the procedure) and 24 hours after the procedure |
| Secondary outcome measures | Symptoms of angina, assessed with the number of angina attacks (chest pain) per week, on the day of inclusion and 1 month after the inclusion |
| Overall study start date | 08/01/2010 |
| Completion date | 06/04/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 80 |
| Total final enrolment | 78 |
| Key inclusion criteria | 1. Patients scheduled for elective PCI 2. Suspected or established coronary artery disease 3. Presence of sinus rhythm 4. Resting heart frequency above 70 beats per minute |
| Key exclusion criteria | 1. Previous pacemaker implantation 2. Symptoms and signs of heart failure 3. Ejection fraction of left ventricle below 50% 4. Levels of creatinine above upper level of normal (ULN) 5. Already treated with ivabradine |
| Date of first enrolment | 17/05/2010 |
| Date of final enrolment | 18/07/2014 |
Locations
Countries of recruitment
- Slovenia
Study participating centre
2000 Maribor
2000
Slovenia
Sponsor information
Hospital/treatment centre
Dpt of cardiology
Ljubljanska 5
Maribor
2000
Slovenia
| Website | www.ukc-mb.si |
|---|---|
"ROR" |
https://ror.org/02rjj7s91 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/08/2018 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The trialists plan to publish the data in an original article in a peer-reviewed journal with an impact factor as soon as possible. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Franjo Naji (franjo.naji@yahoo.com) in anonymised form in an Excel table. The decision to share data depends on the type of inquiry and person involved. No special consent of patients to share the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Abstract results | Presented at ESC Congress 2014 | 30/08/2014 | 05/08/2021 | No | No |
| Results article | 18/03/2021 | 05/08/2021 | Yes | No |
Editorial Notes
05/08/2021:The following changes have been made:
1. Publication reference added.
2. The abstract link has been mved from the publication and dissemination plan to the outputs table.
06/11/2019: The following changes have been made:
1. Conference abstract link added to publication and dissemination plan.
2. The final enrolment number was added from the abstract.
