Ischemic Non-Obstructive Coronary Artery Disease (INOCA) Coronary Spasm,Coronary Microvascular Dysfunction, Combination of Coronary Spasm and Coronary Microvascular Dysfunction
Conditions
Interventions
All subjects will undergo the following tests at registration (Visit 1), 6 months later (Visit 3), and 12 months later (Visit 4):
Cardiopulmonary exercise test (CPX)
Questionnaires (SAQ, ED-5D)
Grip s
D015425
Cardiac Rehabilitation,AI Application "ODOLL",Wearable Activity Tracker
Sponsors
Ono Shoya
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with angina symptoms and no significant stenosis on coronary angiography, identified with one of the endotypes of INOCA (coronary spasm, coronary microvascular dysfunction, or a combination of both) through guidewire-based invasive functional testing. Patients who meet the above criteria, even after undergoing percutaneous coronary intervention (PCI), will be included. Age at registration must be between 20 and 85 years. Gender does not matter. Patients who understand the purpose of this study and can provide written informed consent themselves.
Exclusion criteria
Exclusion criteria: Patients with conditions or diseases for which exercise therapy is contraindicated according to the 2021 guidelines on cardiac rehabilitation, such as unstable angina, severe heart failure, and uncontrolled arrhythmias. Patients who are pregnant, may become pregnant, are breastfeeding, or wish to become pregnant during the study period. Patients currently participating in other interventional clinical studies. Patients with severe cognitive impairment, communication difficulties, or other reasons deemed inappropriate for participation in this study by the attending physician (such as significant physical debilitation or severe visual and auditory impairments).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Peak VO2 (maximum oxygen uptake) from registration to 6 months later in the cardiopulmonary exercise test (CPX). Peak VO2 is a standard indicator for quantitatively evaluating exercise tolerance and is considered highly effective as a prognostic factor in cardiovascular diseases. This item is positioned to objectively reflect the improvement in cardiopulmonary function due to the intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| Anaerobic threshold and ECG changes during CPX (Indicators reflecting cardiopulmonary function and ischemic response) Seattle Angina Questionnaire (Subjective evaluation of the frequency and severity of angina symptoms and their impact on daily life) EuroQOL 5 Dimension (Assessment of health-related quality of life) Grip strength (Simple and objective indicator of physical function) | — |
Contacts
Public ContactTakanori Yasu
Dokkyo Medical University Nikko Medical Center
Outcome results
None listed