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
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