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Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

Primary Purpose

Refractory Angina Pectoris, Ischemic Heart Disease, Coronary Artery Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)
Sponsored by
Storz Medical AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Refractory Angina Pectoris

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Technische Universität München I. Medizinische Klinik und Poliklinik

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Active Shockwave Therapy

Arm Description

Patients in this group receive shockwave therapy.

Outcomes

Primary Outcome Measures

Change of myocardial perfusion reserve (MPR)
Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 14 weeks
Change of myocardial perfusion reserve (MPR)
Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 5 weeks

Secondary Outcome Measures

Enddiastolic volume
Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks
Enddiastolic volume
Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks
Endsystolic volume
Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks
Endsystolic volume
Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks
Stroke volume
Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks
Stroke volume
Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks
Ejection fraction
Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks
Ejection fraction
Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks
Regional wall motion
Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks
Regional wall motion
Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks
Scar extent
Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks
Scar extent
Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks
Diffuse fibrosis
Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks
Diffuse fibrosis
Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks
Severity and frequency of angina
Change from baseline in Seattle Angina questionnaire at 5 weeks
Severity and frequency of angina
Change from baseline in Seattle Angina questionnaire at 14 weeks
New York Heart Association (NYHA) class
Change from baseline in NYHA class at 5 weeks
New York Heart Association (NYHA) class
Change from baseline in NYHA class at 14 weeks
Exercise capacity
Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks
Exercise capacity
Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks
Quality of life (SF-36)
Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 5 weeks
Quality of life (SF-36)
Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 14 weeks
New myocardial scarring or fibrotic changes
Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 5 weeks
New myocardial scarring or fibrotic changes
Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 14 weeks
Myocardial edema
Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks
Myocardial edema
Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks
Myocardial hemorrhage
Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks
Myocardial hemorrhage
Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks

Full Information

First Posted
February 12, 2018
Last Updated
October 26, 2022
Sponsor
Storz Medical AG
Collaborators
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT03438500
Brief Title
Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor & PI decision
Study Start Date
September 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2022 (Anticipated)
Study Completion Date
September 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Storz Medical AG
Collaborators
Technical University of Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Refractory Angina Pectoris, Ischemic Heart Disease, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Shockwave Therapy
Arm Type
Experimental
Arm Description
Patients in this group receive shockwave therapy.
Intervention Type
Device
Intervention Name(s)
Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)
Other Intervention Name(s)
Modulith SLC, Extracorporeal Cardiac Shockwave Therapy (CSWT)
Intervention Description
40 - 60 spots per visit (200 shots/spot) at Energy Level 3
Primary Outcome Measure Information:
Title
Change of myocardial perfusion reserve (MPR)
Description
Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 14 weeks
Time Frame
14 weeks
Title
Change of myocardial perfusion reserve (MPR)
Description
Change from baseline in MPR (assessed with quantitative perfusion cardiac magnetic resonance imaging (cMRI)) at 5 weeks
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Enddiastolic volume
Description
Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks
Time Frame
5 weeks
Title
Enddiastolic volume
Description
Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks
Time Frame
14 weeks
Title
Endsystolic volume
Description
Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks
Time Frame
5 weeks
Title
Endsystolic volume
Description
Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks
Time Frame
14 weeks
Title
Stroke volume
Description
Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks
Time Frame
5 weeks
Title
Stroke volume
Description
Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks
Time Frame
14 weeks
Title
Ejection fraction
Description
Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks
Time Frame
5 weeks
Title
Ejection fraction
Description
Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks
Time Frame
14 weeks
Title
Regional wall motion
Description
Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks
Time Frame
5 weeks
Title
Regional wall motion
Description
Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks
Time Frame
14 weeks
Title
Scar extent
Description
Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks
Time Frame
5 weeks
Title
Scar extent
Description
Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks
Time Frame
14 weeks
Title
Diffuse fibrosis
Description
Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks
Time Frame
5 weeks
Title
Diffuse fibrosis
Description
Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks
Time Frame
14 weeks
Title
Severity and frequency of angina
Description
Change from baseline in Seattle Angina questionnaire at 5 weeks
Time Frame
5 weeks
Title
Severity and frequency of angina
Description
Change from baseline in Seattle Angina questionnaire at 14 weeks
Time Frame
14 weeks
Title
New York Heart Association (NYHA) class
Description
Change from baseline in NYHA class at 5 weeks
Time Frame
5 weeks
Title
New York Heart Association (NYHA) class
Description
Change from baseline in NYHA class at 14 weeks
Time Frame
14 weeks
Title
Exercise capacity
Description
Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks
Time Frame
5 weeks
Title
Exercise capacity
Description
Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks
Time Frame
14 weeks
Title
Quality of life (SF-36)
Description
Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 5 weeks
Time Frame
5 weeks
Title
Quality of life (SF-36)
Description
Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 14 weeks
Time Frame
14 weeks
Title
New myocardial scarring or fibrotic changes
Description
Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 5 weeks
Time Frame
5 weeks
Title
New myocardial scarring or fibrotic changes
Description
Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 14 weeks
Time Frame
14 weeks
Title
Myocardial edema
Description
Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks
Time Frame
5 weeks
Title
Myocardial edema
Description
Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks
Time Frame
14 weeks
Title
Myocardial hemorrhage
Description
Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks
Time Frame
5 weeks
Title
Myocardial hemorrhage
Description
Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks
Time Frame
14 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Georg Schmidt, Prof. Dr.
Organizational Affiliation
Technische Universität München I. Medizinische Klinik und Poliklinik
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alexander Steger, Dr. med.
Organizational Affiliation
Technische Universität München I. Medizinische Klinik und Poliklinik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Technische Universität München I. Medizinische Klinik und Poliklinik
City
München
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No

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Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

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