Coronary Artery Disease, Angina Pectoris
Conditions
Keywords
Coronary Sinus Reducer, Myocardial Ischemia, Coronary Microcirculation
Brief summary
The increasing number of coronary revascularization procedures, coupled with improvements in drug therapy, has significantly extended the lifespan of patients with coronary artery disease (CAD). However, there remains a significant number of CAD patients who experience disability due to chronic refractory angina pectoris. These patients typically have severe diffuse CAD and are not candidates for further revascularization involving surgical coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI). The installation of a coronary sinus reducer (CSR) represents a new option for percutaneous treatment of patients with refractory angina pectoris who are not suitable for surgical or percutaneous revascularization. The CSR device is designed as an hourglass-shaped stent that is positioned transcatheterally in the distal part of the coronary sinus. This increases intramyocardial venous pressure, which is believed to lead to a more favorable perfusion ratio between the ischemic subendocardial and non-ischemic subepicardial myocardium. Previous research has demonstrated that the implantation of CSR is a safe and relatively straightforward procedure. However, broader implementation and better patient selection are still limited by the fact that the exact mechanism of action remains controversial. It has not been determined why some patients have better outcomes compared to others with seemingly similar coronary artery disease. It is known that patients with atherosclerotic changes in the epicardial coronary arteries also have a certain degree of coronary microcirculation disease (the coronary vascular bed encompassing vessels with a diameter \< 200 μm), which cannot be assessed through standard coronary angiography. This study aims to assess changes in coronary microcirculation after the implantation of CSR by measuring coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) before and 6 months after the procedure. Furthermore, our goal is to associate these changes with clinical symptoms and myocardial ischemia.
Interventions
DEVICECoronary Sinus Reducer
Implantation of Coronary Sinus Reducer
Sponsors
Clinical Hospital Centre Zagreb
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single-Center Prospective Study
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Patients with coronary artery disease and refractory angina pectoris who are ineligible for coronary revascularization * Signed informed consent
Exclusion criteria
* Severely reduced systolic ejection fraction of the left ventricle (EF \< 35 %) * Severe renal impairment (eGFR \< 30ml/min/1.73m2) * Severe chronic obstructive pulmonary disease (GOLD D) * Contraindication for application of papaverine or regadenoson
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Coronary Sinus Reducer on Coronary Microcirculation | 2 and half years | Assessment of Coronary Flow Reserve and Index of Microcirculatory Resistance before and after Coronary Sinus Reducer implantation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Angina assessment | 2 and half years | Comparison of the severity of angina pectoris before and 6 months after the procedure using the Canadian Cardiovascular Society angina scale (CCS) and the Seattle Angina Questionnaire-7 (SAQ-7). |
| Functional capacity assessment | 2 and half years | Assessment of functional capacity before and 6 months after the procedure through 6 Minute Walk Test |
| Myocardial Ischemia assessment | 2 and half years | Evaluation of the ischemic zone before and 6 months after the procedure using Perfusion Stress Cardiac Magnetic Resonance |
Countries
Croatia
Contacts
Primary ContactJosko Bulum, MD, PhD
Backup ContactLuka Percin, MD
Outcome results
None listed