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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53243

Enrollment

Registered

2023-06-20

Start date

2025-05-28

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microvascular dysfunction small vessel disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 0.80 4. presence of MVD defined as IMR> 30

Exclusion criteria

Exclusion criteria: * noncardiac origin of chest pain, such as gastrointestinal or musculoskeletal * Recent (

Design outcomes

Primary

Measure	Time frame
Primary endpoint The primary endpoint at 6 months is: - Improvement of the index of microvascular resistance (IMR)	—

Secondary

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

Countries

Netherlands

Outcome results