Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia
Impact of Coronary Sinus Flow Reducer on Coronary Microcirculation and Myocardial Ischemia in Patients With Refractory Angina Pectoris
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Josko Bulum, MD, PhD
- Phone Number: +385981714090
- Email: jbulum@gmail.com
Study Contact Backup
- Name: Luka Percin, MD
- Phone Number: +385917917252
- Email: luka.percin555@gmail.com
Study Locations
-
-
-
Zagreb, Croatia, 10000
- Recruiting
- University Hospital Centre Zagreb
-
Contact:
- Josko Bulum, MD, PhD
- Phone Number: +385981714090
- Email: jbulum@gmail.com
-
Contact:
- Luka Percin, MD
- Phone Number: +385917917252
- Email: luka.percin555@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Coronary Sinus Reducer
|
Implantation of Coronary Sinus Reducer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Impact of Coronary Sinus Reducer on Coronary Microcirculation
Time Frame: 2 and half years
|
Assessment of Coronary Flow Reserve and Index of Microcirculatory Resistance before and after Coronary Sinus Reducer implantation
|
2 and half years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Myocardial Ischemia assessment
Time Frame: 2 and half years
|
Evaluation of the ischemic zone before and 6 months after the procedure using Perfusion Stress Cardiac Magnetic Resonance
|
2 and half years
|
|
Angina assessment
Time Frame: 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).
|
2 and half years
|
|
Functional capacity assessment
Time Frame: 2 and half years
|
Assessment of functional capacity before and 6 months after the procedure through 6 Minute Walk Test
|
2 and half years
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8.1-23/260-2;02/013AG
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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