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CoROnary SinuS Reducer implantatiOn for ischemiA reDuction (CrossRoad)

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ClinicalTrials.gov Identifier: NCT04121845
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Matjaž Bunc, 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).

Condition or disease Intervention/treatment Phase
Refractory Angina Pectoris Device: Coronary Sinus Reducer device Other: Sham procedure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Masking Description: Punction of the right internal jugular vein and CSR implantation procedure simulation.
Primary Purpose: Treatment
Official 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
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angina

Arm Intervention/treatment
Active Comparator: Treatment group
Coronary sinus reducer implantation through right internal jugular vein.
Device: Coronary 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.

Sham Comparator: Sham group
Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.
Other: Sham procedure
Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121845


Contacts
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Contact: MIha Mrak, MD 0038615223125 miha.mrak@kclj.si
Contact: David Žižek, Assoc. Prof. 0038615221152 david.zizek@kclj.si

Locations
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Slovenia
University Medical Centre Ljubljana Recruiting
Ljubljana, Slovenia, 1000
Contact: Miha Mrak, MD    0038615223125    miha.mrak@kclj.si   
Contact: David Žižek, Assoc. Prof.    0038615221152    david.zizek@kclj.si   
Principal Investigator: Matjaž Bunc, Prof.         
Sub-Investigator: Miha Mrak, MD         
Sub-Investigator: David Žižek, Assoc. Prof.         
Sub-Investigator: Nejc Pavšič, MD         
Sponsors and Collaborators
University Medical Centre Ljubljana
Investigators
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Principal Investigator: Matjaž Bunc, Prof. University Medical Centre Ljubljana, Slovenia
Study Chair: David Žižek, Assoc. Prof. University Medical Centre Ljubljana, Slovenia

Publications:

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Responsible Party: Matjaž Bunc, Head of catheterization laboratory, University Medical Centre Ljubljana
ClinicalTrials.gov Identifier: NCT04121845     History of Changes
Other Study ID Numbers: CrossRoad
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All IPD that underlie results in a publication All IPD on special request
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: After study completion and results publication. Not limited.
Access Criteria: All IPD that underlie results in a publication on editor/researcher request. All IPD on special request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Matjaž Bunc, University Medical Centre Ljubljana:
angina pectoris
coronary sinus reducer
quality of life
reversible ischemia
exercise testing
oxygen consumption
Additional relevant MeSH terms:
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Angina Pectoris
Ischemia
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Signs and Symptoms