Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve

October 26, 2022 updated by: Storz Medical AG

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • München, Germany, 81675
        • Technische Universität München I. Medizinische Klinik und Poliklinik

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
14 weeks
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
5 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Enddiastolic volume
Time Frame: 5 weeks
Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 5 weeks
5 weeks
Enddiastolic volume
Time Frame: 14 weeks
Change from baseline in enddiastolic volume (assessed with cMRI and TTE) at 14 weeks
14 weeks
Endsystolic volume
Time Frame: 5 weeks
Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 5 weeks
5 weeks
Endsystolic volume
Time Frame: 14 weeks
Change from baseline in endsystolic volume (assessed with cMRI and TTE) at 14 weeks
14 weeks
Stroke volume
Time Frame: 5 weeks
Change from baseline in stroke volume (assessed with cMRI and TTE) at 5 weeks
5 weeks
Stroke volume
Time Frame: 14 weeks
Change from baseline in stroke volume (assessed with cMRI and TTE) at 14 weeks
14 weeks
Ejection fraction
Time Frame: 5 weeks
Change from baseline in ejection fraction (assessed with cMRI and TTE) at 5 weeks
5 weeks
Ejection fraction
Time Frame: 14 weeks
Change from baseline in ejection fraction (assessed with cMRI and TTE) at 14 weeks
14 weeks
Regional wall motion
Time Frame: 5 weeks
Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 5 weeks
5 weeks
Regional wall motion
Time Frame: 14 weeks
Change from baseline in regional wall motion (assessed with steady state free precession cMRI) at 14 weeks
14 weeks
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
5 weeks
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
14 weeks
Diffuse fibrosis
Time Frame: 5 weeks
Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 5 weeks
5 weeks
Diffuse fibrosis
Time Frame: 14 weeks
Change from baseline in diffuse fibrosis (assessed with T1 mapping) at 14 weeks
14 weeks
Severity and frequency of angina
Time Frame: 5 weeks
Change from baseline in Seattle Angina questionnaire at 5 weeks
5 weeks
Severity and frequency of angina
Time Frame: 14 weeks
Change from baseline in Seattle Angina questionnaire at 14 weeks
14 weeks
New York Heart Association (NYHA) class
Time Frame: 5 weeks
Change from baseline in NYHA class at 5 weeks
5 weeks
New York Heart Association (NYHA) class
Time Frame: 14 weeks
Change from baseline in NYHA class at 14 weeks
14 weeks
Exercise capacity
Time Frame: 5 weeks
Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 5 weeks
5 weeks
Exercise capacity
Time Frame: 14 weeks
Change from baseline in exercise capacity (assessed by the 6-minute walk test) at 14 weeks
14 weeks
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
5 weeks
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
14 weeks
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
5 weeks
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
14 weeks
Myocardial edema
Time Frame: 5 weeks
Change from baseline in myocardial edema (assessed with cMRI) at 5 weeks
5 weeks
Myocardial edema
Time Frame: 14 weeks
Change from baseline in myocardial edema (assessed with cMRI) at 14 weeks
14 weeks
Myocardial hemorrhage
Time Frame: 5 weeks
Change from baseline in myocardial hemorrhage (assessed with cMRI) at 5 weeks
5 weeks
Myocardial hemorrhage
Time Frame: 14 weeks
Change from baseline in myocardial hemorrhage (assessed with cMRI) at 14 weeks
14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Storz Medical AG

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Technical University of Munich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2022

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 16, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSW-1814-SCH-0010-S

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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