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Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03438500
Recruitment Status : Not yet recruiting
First Posted : February 19, 2018
Last Update Posted : September 22, 2021
Sponsor:
Collaborator:
Technische Universität München
Information provided by (Responsible Party):
Storz Medical AG

Study Description
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Brief Summary:
The purpose of the study is to assess the feasibility of Cardiac Shock Wave Treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.

Condition or disease Intervention/treatment Phase
Refractory Angina Pectoris Ischemic Heart Disease Coronary Artery Disease Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC) Not Applicable

Detailed Description:

This is a mono-center, prospective, single arm, pilot study designed to assess the feasibility of the "Cardiac Shock Wave Treatment" in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.

A total of 10 subjects will be enrolled in the study. All enrolled study subjects will be assessed for clinical follow-up at the following intervals: 5 and 14 weeks post CSWT procedure.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve in the Absence of Epicardial Coronary Artery Stenoses: A Pilot Study
Estimated Study Start Date : May 1, 2023
Estimated Primary Completion Date : October 30, 2024
Estimated Study Completion Date : May 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock

Arms and Interventions
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Arm Intervention/treatment
Experimental: Active Shockwave Therapy
Patients in this group receive shockwave therapy.
 Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)
40 - 60 spots per visit (200 shots/spot) at Energy Level 3
Other Names:
  • Modulith SLC
  • Extracorporeal Cardiac Shockwave Therapy (CSWT)


Outcome Measures
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Primary Outcome Measures :
  1. Change of myocardial perfusion reserve (MPR) [ Time Frame: 14 weeks ]
    Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 14 weeks

  2. Change of myocardial perfusion reserve (MPR) [ Time Frame: 5 weeks ]
    Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 5 weeks


Secondary Outcome Measures :
  1. Enddiastolic volume [ Time Frame: 5 weeks ]
    Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks

  2. Enddiastolic volume [ Time Frame: 14 weeks ]
    Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks

  3. Endsystolic volume [ Time Frame: 5 weeks ]
    Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks

  4. Endsystolic volume [ Time Frame: 14 weeks ]
    Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks

  5. Stroke volume [ Time Frame: 5 weeks ]
    Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks

  6. Stroke volume [ Time Frame: 14 weeks ]
    Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks

  7. Ejection fraction [ Time Frame: 5 weeks ]
    Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks

  8. Ejection fraction [ Time Frame: 14 weeks ]
    Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks

  9. Regional wall motion [ Time Frame: 5 weeks ]
    Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks

  10. Regional wall motion [ Time Frame: 14 weeks ]
    Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks

  11. Scar extent [ Time Frame: 5 weeks ]
    Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks

  12. Scar extent [ Time Frame: 14 weeks ]
    Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks

  13. Diffuse fibrosis [ Time Frame: 5 weeks ]
    Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks

  14. Diffuse fibrosis [ Time Frame: 14 weeks ]
    Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks

  15. Severity and frequency of angina [ Time Frame: 5 weeks ]
    Change from baseline in Seattle Angina questionnaire at 5 weeks

  16. Severity and frequency of angina [ Time Frame: 14 weeks ]
    Change from baseline in Seattle Angina questionnaire at 14 weeks

  17. New York Heart Association (NYHA) class [ Time Frame: 5 weeks ]
    Change from baseline in NYHA class at 5 weeks

  18. New York Heart Association (NYHA) class [ Time Frame: 14 weeks ]
    Change from baseline in NYHA class at 14 weeks

  19. Exercise capacity [ Time Frame: 5 weeks ]
    Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks

  20. Exercise capacity [ Time Frame: 14 weeks ]
    Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks

  21. Quality of life (SF-36) [ Time Frame: 5 weeks ]
    Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 5 weeks

  22. Quality of life (SF-36) [ Time Frame: 14 weeks ]
    Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 14 weeks

  23. New myocardial scarring or fibrotic changes [ Time Frame: 5 weeks ]
    Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 5 weeks

  24. New myocardial scarring or fibrotic changes [ Time Frame: 14 weeks ]
    Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 14 weeks

  25. Myocardial edema [ Time Frame: 5 weeks ]
    Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks

  26. Myocardial edema [ Time Frame: 14 weeks ]
    Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks

  27. Myocardial hemorrhage [ Time Frame: 5 weeks ]
    Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks

  28. Myocardial hemorrhage [ Time Frame: 14 weeks ]
    Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of anginal chest pain that prompted a myocardial stress test (nuclear myocardial perfusion imaging, stress echocardiography, or perfusion CMR)
  • Evidence for stress-induced myocardial ischemia in this examination
  • Coronary angiogram showing absence of ≥30% stenosis of epicardial coronary arteries

Exclusion Criteria:

  • Participation in other clinical trials
  • age <18 years
  • Contraindications to under cMRI
  • Contraindications to adenosine (severe chronic obstructive pulmonary disease (COPD), asthma, atrioventricular block (AV block) > grade 1)
  • Left ventricular thrombus
  • Uncontrolled diabetes mellitus
  • Uncontrolled arterial hypertension,
  • Any other severe chronic illness such as liver or renal failure (glomerular filtration rate (GFR) < 45 ml/min), active neoplastic disease, history of myocardial infarction or coronary revascularization within the past three months
  • Patients with pacemaker or implanted cardioverter defibrillator
  • Patients after valve surgical replacement
  • Patients after interventional valve replacement or reconstruction (e.g. transfemoral aortic valve replacement or MitraClip implantation)
  • Pregnancy (a reliable method of contraception must be used for the entire duration of the study)
  • Fertile female participants who are capable of bearing children and who do not use a method of contraception that is medically approved by the health authority of the respective country
  • Missing capacity to consent
Contacts and Locations
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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): NCT03438500


Contacts
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Contact: Rafael Storz, Dr. +41 (0)71 677 45 45 cswt-study@storzmedical.com
Contact: Markus Belau, Dr. +41 (0)71 677 45 45 cswt-study@storzmedical.com

Locations
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Germany
Technische Universität München I. Medizinische Klinik und Poliklinik
München, Germany, 81675
Sponsors and Collaborators
Storz Medical AG
Technische Universität München
Investigators
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Principal Investigator: Georg Schmidt, Prof. Dr. Technische Universität München I. Medizinische Klinik und Poliklinik
Principal Investigator: Alexander Steger, Dr. med. Technische Universität München I. Medizinische Klinik und Poliklinik
More Information
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Responsible Party: Storz Medical AG
ClinicalTrials.gov Identifier: NCT03438500    
Other Study ID Numbers: CSW-1814-SCH-0010-S
First Posted: February 19, 2018    Key Record Dates
Last Update Posted: September 22, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Angina Pectoris
Coronary Disease
Cardiovascular Diseases
 Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations