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Completed

NCT Number: NCT04121845

CoROnary SinuS Reducer implantatiOn for ischemiA reDuction

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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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Medical Centre Ljubljana

Ljubljana, 1000, Slovenia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary Sinus Reducer device

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.

Sham Procedure

Other

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

Primary outcomes

  1. Impact of CSR versus placebo procedure on exertional capacity measured by maximal oxygen consumption (VO2) during cardio-pulmonary exercise testing.

    Time frame: 6 months

    Maximal oxygen consumption on cycle spiroergometry using the same ramp exercise protocol during the same part of the day.

Secondary outcomes

  1. Impact of CSR versus placebo procedure on exercise duration time during cardio-pulmonary exercise testing.

    Time frame: 6 months

    Exercise duration time on cycle spiroergometry using the same continuous exercise protocol during the same part of the day.

  2. Change in the extent of myocardial reversible ischemia calculated by single-photon emission computed tomography (dynamic scintigraphy).

    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.

  3. Change in the extent of myocardial reversible ischemia calculated by single-photon emission computed tomography (static scintigraphy).

    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.

  4. Change in RR interval variability as assessed by hrECG.

    Time frame: 6 months

    5 min recording of hrECG (1000 Hz) for the calculation of RR interval variability.

  5. Change in late potentials as assessed by hrECG.

    Time frame: 6 months

    5 min recording of hrECG (1000 Hz) for the calculation of late potentials.

  6. Change in QT variability as assessed by hrECG.

    Time frame: 6 months

    5 min recording of hrECG (1000 Hz) for determination of QT variability.

  7. Change in Canadian Cardiovascular Society angina pectoris class (CCS).

    Time frame: 3 months, 6 months

    Change in CCS class I-IV. Acco

  8. Impact of CSR versus placebo procedure on quality of life according to Seattle angina questionnaire (SAQ).

    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.

Other outcomes

  1. Influence of CSR implantation on echocardiographically assessed left ventricular elastance.

    Time frame: 6 months

  2. Influence of CSR implantation on diastolic strain.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University Medical Centre Ljubljana

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 10, 2019
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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