NCT03438500

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 12, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 19, 2018

Completed
4.5 years until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

October 31, 2022

Status Verified

October 1, 2022

Enrollment Period

Same day

First QC Date

February 12, 2018

Last Update Submit

October 26, 2022

Conditions

Refractory Angina PectorisIschemic Heart DiseaseCoronary Artery Disease

Outcome Measures

Primary Outcomes (2)

  • Change of myocardial perfusion reserve (MPR)

    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)

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

    5 weeks

Secondary Outcomes (28)

  • Enddiastolic volume

    5 weeks

  • Enddiastolic volume

    14 weeks

  • Endsystolic volume

    5 weeks

  • Endsystolic volume

    14 weeks

  • Stroke volume

    5 weeks

  • +23 more secondary outcomes

Study Arms (1)

Active Shockwave Therapy

EXPERIMENTAL

Patients in this group receive shockwave therapy.

Device: Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)

Interventions

Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)DEVICE

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

Also known as: Modulith SLC, Extracorporeal Cardiac Shockwave Therapy (CSWT)
Active Shockwave Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Technische Universität München I. Medizinische Klinik und Poliklinik

München, 81675, Germany

Location

MeSH Terms

Conditions

Angina PectorisMyocardial IschemiaCoronary Artery Disease

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCoronary DiseaseArteriosclerosisArterial Occlusive Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 19, 2018

Study Start

September 1, 2022

Primary Completion

September 1, 2022

Study Completion

September 1, 2022

Last Updated

October 31, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)