Clinical trial NCT06266065: Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia
Official title: Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia in Patients With Refractory Angina Pectoris
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Angina Pectoris
Keywords: Coronary Sinus Reducer
Myocardial Ischemia
Coronary Microcirculation
Lead sponsor: Clinical Hospital Centre Zagreb
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single-Center Prospective Study
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Impact of Coronary Sinus Reducer on Coronary Microcirculation
timeFrame: 2 and half years
Secondary outcomes:
measure: Myocardial Ischemia assessment
timeFrame: 2 and half years
measure: Angina assessment
timeFrame: 2 and half years
measure: Functional capacity assessment
timeFrame: 2 and half years
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Centre Zagreb
Study officials:
References: