Shockwave Treatment for Advanced Angina in Maastricht
- Conditions
- Angina
- Registration Number
- NCT01361659
- Lead Sponsor
- Maastricht University Medical Center
- Brief Summary
There is an increasing number of patients with a coronary anatomy that does not allow additional revascularization procedures, while the patients suffer from angina pectoris at rest or at minimal exercise levels despite optimised medical therapy. There is a lack of therapeutic options for this group of so called "no-option patients". Goal of the project is to implement the shockwave therapy for no-option coronary artery disease patients and to evaluate its potential benefit on regional myocardial perfusion, on regional myocardial function and on the potential improvement in symptoms and quality of life.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- Chronic angina pectoris CCS (Canadian Cardiological Society) III or IV with documented reversible ischemia and/or hibernation.
- Patients demonstrates exercise tolerance test (ETT) duration < 10 minutes on a modified Bruce protocol
- No possibility of traditional revascularization by coronary artery bypass grafting (CABG) or Percutaneous coronary intervention (PCI)
- Patient's conditions stable for at least 3 months
- Life expectancy of > 12 months.
- Unstable angina pectoris
- Haemodynamically significant valvular heart disease
- Myocardial infarction <3 month prior randomization
- Evidence of intracardiac thrombus
- Contraindication for Magnetic resonance imaging (MRI) (pacemaker, metallic prostheses)
- Patient is simultaneously participating in another device or drug study, or has participated in any clinical trial involving an experimental device or drug, including other drugs or devices enhancing cardiac neovascularization or any Extracorporeal Shock Wave Therapy (ESWT) machine for neovascularization of a competitor company within 3 months of entry into the study.
- Patients who are unwilling or unable to cooperate with the study procedure.
- Age < 18 years
- Cardiac or pulmonary malignancy
- No informed consent
- Known depression
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Improvement of exercise tolerance after 6 months Modified Bruce protocol, changes compared to the baseline
- Secondary Outcome Measures
Name Time Method Improvement of myocardial perfusion 6 months myocardial perfusion scintigraphy changes compared to the baseline
Number of Patients with Adverse Events as a Measure of Safety 6 months Changes in electrocardiogram and cardiac enzymes (e.g. creatininekinase, troponin), clinical status and chestpain.
Improvement of quality of life 6 months Number of anginal attacks/week, use of nitrates/week
Trial Locations
- Locations (1)
Maastricht University Medical Center
🇳🇱Maastricht, Limburg, Netherlands