Patients with Angina and MicrOvaScular DysfunctIon treaTed with cardiac non-InVasivE SHOCK wave therapy, a first in man pioneering trial -POSITIVE SHOCK

Conditions: Microvascular dysfunction
small vessel disease
10011082

Registration Number: NL-OMON53243

Lead Sponsor: cardiologie

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

1. Stable Angina, defined as: - Angina with exercise or rest - Exertional
dyspnea 2. Age >=18 years 3. Angina without flow limiting CAD defined as
epicardial stenosis <50% or FFR >0.80 4. presence of MVD defined as
IMR> 30

Exclusion Criteria

* noncardiac origin of chest pain, such as gastrointestinal or musculoskeletal
* Recent (<3 months) myocardial infarction * Severe aortic valve stenosis/
elevated LVEDP * History of coronary artery bypass graft * Known cardiomyopathy
or myocarditis * Bad acoustic windows in supine position * LV thrombus * ICD/
pacemaker * Extra-cardiac illness that is expected to limit survival to less
than 1 years * Active participation in another trial * Unable to give informed
consent or potential for noncompliance with the study protocol in the judgment
of the investigator * Pregnant at the time of screening or unwilling to use
effective birth control measures

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint<br /><br>The primary endpoint at 6 months is:<br /><br>- Improvement of the index of microvascular resistance (IMR) </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary outcomes at 6 months are:<br /><br>- Improvement in invasive parameter of MVD measured as coronary flow reserve<br /><br>(CFR)<br /><br>- Self (patient)-assessed angina score and quality of life, assessed with the<br /><br>Seattle Angina and SF-36 Questionnaire<br /><br>- Improvement of exercise capacity measured in metabolic equivalents (MET)<br /><br>scores during bicycle test<br /><br>- Use of short-acting nitrates</p><br>