University Medical Centre Ljubljana
Ljubljana, 1000, Slovenia
NCT Number: NCT04121845
Patients with refractory angina pectoris have low quality of life and reduced exertional capacity. Studies have shown that the coronary sinus reducer (CSR) implantation improves the quality of life. However, to date there are no firm objective data on improvement of exertional capacity. Studies have shown a large influence of placebo effect after interventional procedures, which is even more pronounced than in medically treated patients. As angina pectoris presents entirely subjective perception of chest discomfort, its improvement may be influenced by this effect in up to 30 %. The investigators will study weather the CSR implantation improves aerobic exertional capacity in comparison to optimal medical therapy alone. Further, the investigators will explore the extent of myocardial reversible ischemia reduction and possible influence on hrECG markers of left ventricular arrhythmogenicity. 40 patients with refractory angina CCS class (Canadian cardiovascular society) II-IV and confirmed reversible ischemia will be included. Patients will be randomized into two groups. The first group will undergo CSR implantation procedure. The second group will present a sham control group with placebo procedure. At inclusion and after 6 months the investigators will perform cardiopulmonary exercise test (CPET), single photon emission tomography for detection of reversible ischemia (SPECT), high resolution ECG (hrECG), echocardiography and asses the subjective burden of angina according to CCS score and the quality of life according to the Seattle angina Questionnaire (SAQ).
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Notify Me18 year–85 year
All sexes
Interventional
Not applicable
Ljubljana, 1000, Slovenia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Coronary sinus reducer device (Neovasc, Richomnd, Canada) implantation in the coronary sinus. The procedure is performed in the cardiac catheterization laboratory through right internal jugular vein.
Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.
Time frame: 6 months
Maximal oxygen consumption on cycle spiroergometry using the same ramp exercise protocol during the same part of the day.
Time frame: 6 months
Exercise duration time on cycle spiroergometry using the same continuous exercise protocol during the same part of the day.
Time frame: 6 months
Dynamic myocardial scintigraphy with the use of a 4 segment model of the left ventricle for calculation of absolute regional perfusion (ml/g/min) during rest and during pharmacologic stress. Change in the extent of myocardial reversible ischemia calculated by single-photon emission computed tomography.
Time frame: 6 months
Static myocardial scintigraphy with the use of a 17 segment model for the relative calculation of regional perfusion during rest and pharmacologic stress.
Time frame: 6 months
5 min recording of hrECG (1000 Hz) for the calculation of RR interval variability.
Time frame: 6 months
5 min recording of hrECG (1000 Hz) for the calculation of late potentials.
Time frame: 6 months
5 min recording of hrECG (1000 Hz) for determination of QT variability.
Time frame: 3 months, 6 months
Change in CCS class I-IV. Acco
Time frame: 3 months, 6 months
Change in each of the five categories: Physical Limitation Scale (range 1-100), Anginal Stability Scale (range 1-100), Anginal Frequency Scale (range 1-100), Treatment Satisfaction Scale (range 1-100), Disease Perception Scale (range 1-100). Higher values in scale represent better outcome. Subscales are not combined.
Time frame: 6 months
Time frame: 6 months
University Medical Centre Ljubljana
Other
The Influence of Coronary Sinus Reducer Implantation on Exertional Capacity, Extent of Myocardial Ischemia and hrECG Markers of Arrhythmogenicity in Patients With Refractory Angina Pectoris
Acronym: CrossRoad
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