CoROnary SinuS Reducer implantatiOn for ischemiA reDuction

Not Applicable

Completed

• Conditions: Refractory Angina Pectoris

• Registration Number: NCT04121845
• Lead Sponsor: University Medical Centre Ljubljana

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-10-06
• Study First Submitted QC: 2019-10-08
• Study First Posted: 2019-10-10
• Primary Completion: 2021-12-31
• Study Completion: 2022-06-30
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 QT variability as assessed by hrECG.	6 months	5 min recording of hrECG (1000 Hz) for determination of QT 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 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 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 late potentials as assessed by hrECG.	6 months	5 min recording of hrECG (1000 Hz) for the calculation of late potentials.
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.

Trial Locations

Locations (1)

University Medical Centre Ljubljana; 🇸🇮 Ljubljana, Slovenia