Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve (NCT03438500) | Clinical Trial Compass
WithdrawnNot Applicable
Cardiac Shock Wave Treatment in Patients With Reduced Coronary Flow Reserve
Stopped: Sponsor \& PI decision
Germany0Started 2022-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.