Condition category
Circulatory System
Date applied
29/06/2018
Date assigned
06/07/2018
Last edited
06/07/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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.

Trial website

Contact information

Type

Scientific

Primary contact

Dr Franjo Naji

ORCID ID

http://orcid.org/0000-0002-1425-4189

Contact details

Ljubljanska ulica 5
Maribor
2000
Slovenia
+386 (0)23212371
franjo.naji@yahoo.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2010/5

Study information

Scientific title

Effect of heart rate reduction on periprocedural myocardial injury and angina symptoms in elective patients with coronary disease undergoing coronary intervention

Acronym

Study hypothesis

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

Institutional ethics committee University Clinical center Maribor, 05/05/2010, approval Nr: 092-30/2010

Study design

Single-center interventional 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 contact details to request a participant information sheet

Condition

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

Phase

Phase IV

Drug names

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 trial start date

08/01/2010

Overall trial end date

06/04/2016

Reason abandoned (if study stopped)

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

80

Participant 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

Recruitment start date

17/05/2010

Recruitment end date

18/07/2014

Locations

Countries of recruitment

Slovenia

Trial participating centre

University clinical center Maribor
Ljubljanska 5
2000 Maribor
2000
Slovenia

Sponsor information

Organisation

University clinical center Maribor

Sponsor details

Dpt of cardiology
Ljubljanska 5
Maribor
2000
Slovenia

Sponsor type

Hospital/treatment centre

Website

www.ukc-mb.si

Funders

Funder type

Industry

Funder name

Servier

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

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 statement
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.

Intention to publish date

01/08/2018

Participant level data

Available on request

Basic results (scientific)

There were no significant differences between both groups. We noticed significant reduction of heart rate and angina episodes per week in the ivabradine group (62.3±7.1 bpm vs.79±10.2 bpm; P<0.05 and 0.5±1.5 vs. 2.4±2.1; P<0.05). The mean troponin I levels after the procedure were significantly lower in the ivabradine group compared to the control group (0.1±0.3 ng/mL vs. 0.5±0.9 ng/mL; P<0.05). When analyzing patients with performed coronary intervention the only significant predictors of PMI after adjustment for potential confounders in multivariable logistic model were heart rate under 70 bpm (OR 7.0; CI 1.2 to 41.7; P=0.03) and number of deployed stents (OR4.4; 95% CI 1.1 to 17.3; P=0.03).

Publication list

none

Publication citations

Additional files

Editorial Notes