CoROnary SinuS Reducer implantatiOn for ischemiA reDuction (CrossRoad)

University Medical Centre Ljubljana

Status: Completed

Conditions: Refractory Angina Pectoris

Treatments: Device: Coronary Sinus Reducer device; Other: Sham procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04121845

CrossRoad

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Treatment group

Active Comparator group

Description:

Coronary sinus reducer implantation through right internal jugular vein.

Treatment:

Device: Coronary Sinus Reducer device

Sham group

Sham Comparator group

Description:

Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.

Treatment:

Other: Sham procedure