AzTrials
AzTrials

Refractory Angina PectorisNCT03438500

Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

A study testing Cardiac Extracorporeal Shockwave Therapy (Modulith SLC) in people with Refractory Angina Pectoris and Ischemic Heart Disease, run by Storz Medical AG at 1 site in Germany.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteGermany
Study dates
1 Sep 2022to 1 Sep 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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Technische Universität München I. Medizinische Klinik und Poliklinik

    München, 81675

Other trials in Germany

About this study

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

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.

Read the 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.

Being tested
Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)
Medical subject headings
Angina Pectoris, Myocardial Ischemia, Coronary Artery Disease

What participants receive

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

  • Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)Device

    Also called Modulith SLC, Extracorporeal Cardiac Shockwave Therapy (CSWT)

    40 - 60 spots per visit (200 shots/spot) at Energy Level 3

Study groups in NCT03438500
Study groupRoleWhat they receive
Active Shockwave TherapyExperimentalPatients in this group receive shockwave therapy.
Receives: Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)

What is being measured

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

  1. Change of myocardial perfusion reserve (MPR)

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

    Measured: 14 weeks

  2. Change of myocardial perfusion reserve (MPR)

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

    Measured: 5 weeks

Secondary outcomes (28)

  1. Enddiastolic volume

    Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks

    Measured: 5 weeks

  2. Enddiastolic volume

    Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks

    Measured: 14 weeks

  3. Endsystolic volume

    Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks

    Measured: 5 weeks

  4. Endsystolic volume

    Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks

    Measured: 14 weeks

  5. Stroke volume

    Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks

    Measured: 5 weeks

  6. Stroke volume

    Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks

    Measured: 14 weeks

  7. Ejection fraction

    Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks

    Measured: 5 weeks

  8. Ejection fraction

    Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks

    Measured: 14 weeks

  9. Regional wall motion

    Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks

    Measured: 5 weeks

  10. Regional wall motion

    Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks

    Measured: 14 weeks

  11. Scar extent

    Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 5 weeks

    Measured: 5 weeks

  12. Scar extent

    Change from baseline in scar extent (assessed with late gadolinium enhancement cardiac magnetic resonance imaging (LGE cMRI)) at 14 weeks

    Measured: 14 weeks

  13. Diffuse fibrosis

    Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks

    Measured: 5 weeks

  14. Diffuse fibrosis

    Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks

    Measured: 14 weeks

  15. Severity and frequency of angina

    Change from baseline in Seattle Angina questionnaire at 5 weeks

    Measured: 5 weeks

  16. Severity and frequency of angina

    Change from baseline in Seattle Angina questionnaire at 14 weeks

    Measured: 14 weeks

  17. New York Heart Association (NYHA) class

    Change from baseline in NYHA class at 5 weeks

    Measured: 5 weeks

  18. New York Heart Association (NYHA) class

    Change from baseline in NYHA class at 14 weeks

    Measured: 14 weeks

  19. Exercise capacity

    Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks

    Measured: 5 weeks

  20. Exercise capacity

    Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks

    Measured: 14 weeks

  21. Quality of life (SF-36)

    Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 5 weeks

    Measured: 5 weeks

  22. Quality of life (SF-36)

    Change from baseline in quality of life (assessed with questionnaire Short Form (SF-36) Health Survey) at 14 weeks

    Measured: 14 weeks

  23. New myocardial scarring or fibrotic changes

    Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 5 weeks

    Measured: 5 weeks

  24. New myocardial scarring or fibrotic changes

    Change from baseline in new myocardial scarring or fibrotic changes (assessed with LGE cMRI) at 14 weeks

    Measured: 14 weeks

  25. Myocardial edema

    Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks

    Measured: 5 weeks

  26. Myocardial edema

    Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks

    Measured: 14 weeks

  27. Myocardial hemorrhage

    Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks

    Measured: 5 weeks

  28. Myocardial hemorrhage

    Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks

    Measured: 14 weeks

Timeline

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

  1. First posted19 Feb 2018
  2. Study start1 Sep 2022 (estimated)
  3. Primary completion1 Sep 2022 (estimated)
  4. Study completion1 Sep 2022 (estimated)

Why it stopped: Sponsor \& PI decision

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03438500
Sponsor's protocol ID
CSW-1814-SCH-0010-S
Status last verified
Oct 2022
First submitted
12 Feb 2018
Last updated
31 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Cardiac Extracorporeal Shockwave Therapy (Modulith SLC) in people with Refractory Angina Pectoris and Ischemic Heart Disease, run by Storz Medical AG at 1 site in Germany.

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 3 inclusion and 14 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: withdrawn, as of the sponsor's last update on 31 Oct 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 Germany. 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. 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 was withdrawn before enrolling participants, so there are no results.

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?

Change of myocardial perfusion reserve (MPR) (time frame: 14 weeks). The study lists 2 primary outcomes in all. 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 NCT03438500.

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 31 Oct 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in