Refractory Angina Pectoris
Conditions
Keywords
angina pectoris, coronary sinus reducer, quality of life, reversible ischemia, exercise testing, oxygen consumption
Brief summary
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).
Interventions
DEVICECoronary Sinus Reducer device
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.
OTHERSham procedure
Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.
Sponsors
University Medical Centre Ljubljana
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
Punction of the right internal jugular vein and CSR implantation procedure simulation.
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* angina pectoris CCS class II-IV * receiving optimal medical therapy for at least one month * confirmed reversible myocardial ischemia in left anterior descending coronary artery (LAD) and/or left circumflex coronary artery (LCX) territory by SPECT * not candidate for percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
Exclusion criteria
* recent non stable angina pectoris (within 1 months) * recent acute coronary syndrome (within 3 months) * recent successful PCI and/or CABG (within 6 months) * decompensated heart failure and/or recent (within 3 months) hospitalization due to heart failure * severe heart valve(s) disease * advanced chronic obstructive pulmonary disease (COPD) or poorly managed asthma * peripheral arterial disease, musculoskeletal disorder or central nervous system disease which preclude exercise testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of CSR versus placebo procedure on exertional capacity measured by maximal oxygen consumption (VO2) during cardio-pulmonary exercise testing. | 6 months | Maximal oxygen consumption on cycle spiroergometry using the same ramp exercise protocol during the same part of the day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of CSR versus placebo procedure on exercise duration time during cardio-pulmonary exercise testing. | 6 months | Exercise duration time on cycle spiroergometry using the same continuous exercise protocol during the same part of the day. |
| Change in the extent of myocardial reversible ischemia calculated by single-photon emission computed tomography (dynamic scintigraphy). | 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. |
| Change in the extent of myocardial reversible ischemia calculated by single-photon emission computed tomography (static scintigraphy). | 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. |
| Change in RR interval variability as assessed by hrECG. | 6 months | 5 min recording of hrECG (1000 Hz) for the calculation of RR interval variability. |
| Change in Canadian Cardiovascular Society angina pectoris class (CCS). | 3 months, 6 months | Change in CCS class I-IV. Acco |
| Impact of CSR versus placebo procedure on quality of life according to Seattle angina questionnaire (SAQ). | 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. |
| Change in late potentials as assessed by hrECG. | 6 months | 5 min recording of hrECG (1000 Hz) for the calculation of late potentials. |
| Change in QT variability as assessed by hrECG. | 6 months | 5 min recording of hrECG (1000 Hz) for determination of QT variability. |
Other
| Measure | Time frame |
|---|---|
| Influence of CSR implantation on echocardiographically assessed left ventricular elastance. | 6 months |
| Influence of CSR implantation on diastolic strain. | 6 months |
Countries
Slovenia
Outcome results
None listed