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Refractory Angina PectorisCrossRoadNCT04121845

CoROnary SinuS Reducer implantatiOn for ischemiA reDuction

A study testing Coronary Sinus Reducer device in people with Refractory Angina Pectoris, run by University Medical Centre Ljubljana at 1 site in Slovenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Refractory Angina Pectoris
What is being tested?
Coronary Sinus Reducer device
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
25 participants
Where
1 siteSlovenia
Study dates
1 Jan 2019to 30 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Slovenia1 site

  • University Medical Centre Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

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

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).

Being tested
Coronary Sinus Reducer device, Sham procedure
Keywords
angina pectoris, coronary sinus reducer, quality of life, reversible ischemia, exercise testing, oxygen consumption
Medical subject headings
Angina Pectoris

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary Sinus Reducer deviceDevice

    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 procedureOther

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

Study groups in NCT04121845
Study groupRoleWhat they receive
Treatment groupActive comparatorCoronary sinus reducer implantation through right internal jugular vein.
Receives: Device: Coronary Sinus Reducer device
Sham groupSham comparatorPuncture of the right internal jugular vein and simulation of the CSR implantation procedure.
Receives: Other: Sham procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: 6 months

Secondary outcomes (8)

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

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

    Measured: 6 months

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

    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.

    Measured: 6 months

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

    Static myocardial scintigraphy with the use of a 17 segment model for the relative calculation of regional perfusion during rest and pharmacologic stress.

    Measured: 6 months

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

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

    Measured: 6 months

  5. Change in late potentials as assessed by hrECG.

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

    Measured: 6 months

  6. Change in QT variability as assessed by hrECG.

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

    Measured: 6 months

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

    Change in CCS class I-IV. Acco

    Measured: 3 months, 6 months

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

    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.

    Measured: 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Oct 2019
  2. Study start1 Jan 2019
  3. Primary completion31 Dec 2021
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04121845
Sponsor's protocol ID
CrossRoad
Acronym
CrossRoad
Status last verified
Jul 2022
First submitted
6 Oct 2019
Last updated
25 Jul 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All IPD that underlie results in a publication All IPD on special request

Publications

  • Mannheimer C, Camici P, Chester MR, Collins A, DeJongste M, Eliasson T, Follath F, Hellemans I, Herlitz J, Luscher T, Pasic M, Thelle D. The problem of chronic refractory angina; report from the ESC Joint Study Group on the Treatment of Refractory Angina. Eur Heart J. 2002 Mar;23(5):355-70. doi: 10.1053/euhj.2001.2706. No abstract available.

    PubMed 11846493

  • Henry TD, Satran D, Hodges JS, Johnson RK, Poulose AK, Campbell AR, Garberich RF, Bart BA, Olson RE, Boisjolie CR, Harvey KL, Arndt TL, Traverse JH. Long-term survival in patients with refractory angina. Eur Heart J. 2013 Sep;34(34):2683-8. doi: 10.1093/eurheartj/eht165. Epub 2013 May 12.

    PubMed 23671156

  • Giannini F, Aurelio A, Jabbour RJ, Ferri L, Colombo A, Latib A. The coronary sinus reducer: clinical evidence and technical aspects. Expert Rev Cardiovasc Ther. 2017 Jan;15(1):47-58. doi: 10.1080/14779072.2017.1270755.

    PubMed 27935738

  • Konigstein M, Verheye S, Jolicoeur EM, Banai S. Narrowing of the Coronary Sinus: A Device-Based Therapy for Persistent Angina Pectoris. Cardiol Rev. 2016 Sep-Oct;24(5):238-43. doi: 10.1097/CRD.0000000000000101.

    PubMed 26886464

  • Verheye S, Jolicoeur EM, Behan MW, Pettersson T, Sainsbury P, Hill J, Vrolix M, Agostoni P, Engstrom T, Labinaz M, de Silva R, Schwartz M, Meyten N, Uren NG, Doucet S, Tanguay JF, Lindsay S, Henry TD, White CJ, Edelman ER, Banai S. Efficacy of a device to narrow the coronary sinus in refractory angina. N Engl J Med. 2015 Feb 5;372(6):519-27. doi: 10.1056/NEJMoa1402556.

    PubMed 25651246

  • Konigstein M, Meyten N, Verheye S, Schwartz M, Banai S. Transcatheter treatment for refractory angina with the Coronary Sinus Reducer. EuroIntervention. 2014 Feb;9(10):1158-64. doi: 10.4244/EIJV9I10A196.

    PubMed 24561732

  • Abawi M, Nijhoff F, Stella PR, Voskuil M, Benedetto D, Doevendans PA, Agostoni P. Safety and efficacy of a device to narrow the coronary sinus for the treatment of refractory angina: A single-centre real-world experience. Neth Heart J. 2016 Sep;24(9):544-51. doi: 10.1007/s12471-016-0862-2.

    PubMed 27299456

  • Banai S, Ben Muvhar S, Parikh KH, Medina A, Sievert H, Seth A, Tsehori J, Paz Y, Sheinfeld A, Keren G. Coronary sinus reducer stent for the treatment of chronic refractory angina pectoris: a prospective, open-label, multicenter, safety feasibility first-in-man study. J Am Coll Cardiol. 2007 May 1;49(17):1783-9. doi: 10.1016/j.jacc.2007.01.061.

    PubMed 17466229

  • Myers J, Froelicher VF. Optimizing the exercise test for pharmacological investigations. Circulation. 1990 Nov;82(5):1839-46. doi: 10.1161/01.cir.82.5.1839.

    PubMed 2225380

  • Kralios AC, Nappi JM, Tsagaris TJ, Kralios FA, Kuida H. Paradoxical increase of ventricular fibrillation threshold in response to coronary sinus obstruction. Am Heart J. 1988 Feb;115(2):334-40. doi: 10.1016/0002-8703(88)90479-6.

    PubMed 3341168

  • Kralios AC, Anderson FL, Kralios FA. Protective effect of coronary sinus obstruction from primary ischemia-induced ventricular fibrillation in the dog. Am Heart J. 1993 Apr;125(4):987-95. doi: 10.1016/0002-8703(93)90105-i.

    PubMed 8465771

  • De Maria GL, Kassimis G, Raina T, Banning AP. Reconsidering the back door approach by targeting the coronary sinus in ischaemic heart disease. Heart. 2016 Aug 15;102(16):1263-9. doi: 10.1136/heartjnl-2016-309642. Epub 2016 Jun 10.

    PubMed 27288281

  • Baldetti L, Colombo A, Banai S, Latib A, Esposito A, Palmisano A, Giannini F. Coronary sinus Reducer non-responders: insights and perspectives. EuroIntervention. 2018 Feb 20;13(14):1667-1669. doi: 10.4244/EIJ-D-17-00626.

    PubMed 29086709

  • Mrak M, Zlahtic T, Starc V, Ivanovski M, Bunc M, Zizek D. The Impact of Coronary Sinus Reducer on Arrhythmic Properties in Patients with Refractory Angina. Rev Cardiovasc Med. 2023 Dec 26;24(12):368. doi: 10.31083/j.rcm2412368. eCollection 2023 Dec.

    PubMed 39077099

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Sinus Reducer device in people with Refractory Angina Pectoris, run by University Medical Centre Ljubljana at 1 site in Slovenia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Impact of CSR versus placebo procedure on exertional capacity measured by maximal oxygen consumption (VO2) during cardio-pulmonary exercise testing. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04121845, which also lists 14 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2022.

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