Ivabradine and PCI related microcirculatory dysfunction
Research type
Research Study
Full title
Can Ivabradine attenuate post-revascularisation microcirculatory dysfunction in flow limiting coronary artery disease?
IRAS ID
164872
Contact name
Aleem Khand
Contact email
Sponsor organisation
Liverpool Heart and Chest Hospital
Eudract number
2015-003260-37
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 0 months, 5 days
Research summary
The aim of the study is to assess whether ivabradine (a relatively novel angina drug) compared to conventional beta blockers, may reduce the incidence of myocardial/microvascular injury after percutaneous intervention (PCI) for patients with angina. Patients with angina and significant coronary artery narrowing on angiogram benefit from treatment with angioplasty on symptomatic grounds. Recently there has been interest in the phenomenon of peri-procedural myocardial injury after elective PCI. One element of this relates to coronary microvascular dysfunction caused by damage to the smaller coronary vessels that are not visible on angiography. Multiple theories on the mechanisms behind these injuries exist. It has been shown that patients experiencing them may have a worse prognosis. It is therefore important to consider strategies to limit the extent of such phenomena. Ivabradine, has been shown to have different and potentially more beneficial effects on the coronary vascular system compared to conventional beta blocker therapy including improvement in microvascular flow and collateral vessel development. We hypothesise that ivabradine may reduce microvascular injury after PCI. This is measurable by new catheter based techniques during the PCI procedure (such as index of microvascular function (IMR)). The study will therefore identify patients referred for PCI as per usual management, then randomise them to standard (beta blocker) therapy or ivabradine for 6 weeks prior to it. Microvascular dysfunction (as IMR) and other measurements will be taken during and after the PCI procedure. The research will be conducted at a high volume PCI centre (Liverpool Heart and Chest Hospital) in patients who would be planned for the procedure anyway. The extra procedural measurements required would add a small amount of time to the procedure with minimal risk. Patients would be followed up 3 months after PCI with magnetic resonance imaging (MRI) scans and assessment of symptoms as compared to baseline.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
15/NW/0720
Date of REC Opinion
20 Oct 2015
REC opinion
Further Information Favourable Opinion