Percutaneous coronary intervention
Conditions
Interventions
Intervention Group 2:Standardized Health Management Team
Intervention Group 1:Standardized digital breathing exercises based on the 'AuraFlow' system
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Disease diagnosis criteria: Chronic coronary heart disease (confirmed diagnosis): Having a clear history of PCI (percutaneous coronary intervention) with the procedure performed more than 3 months prior to enrollment. Clinically stable, meeting the diagnosis of chronic coronary heart disease or stable angina pectoris. Resting left ventricular ejection fraction (LVEF) >= 50% (confirmed by echocardiography). e. Mild anxiety disorder (quantitative assessment); 2. Generalized anxiety disorder 7-item scale (GAD-7) score between 5 and 9 (i.e., within the mild anxiety category). 3. Medical history and treatment: Having received at least 3 months of standardized pharmacotherapy for secondary prevention of coronary heart disease (including but not limited to antiplatelet drugs, statin lipid-lowering drugs, beta blockers, and/or ACEI/ARB drugs), with no significant changes in the regimen in the recent period (within 1 month). Able to understand and willing to sign the informed consent form. Willing and able to comply with all visit, treatment, and evaluation procedures specified in the study protocol. 4. Demographic criteria: Aged between 30 and 65 years (inclusive), of either gender.
Exclusion criteria
Exclusion criteria: 1. Subjects who meet any of the following criteria are not eligible to participate in this study: (1) Cardiac-related conditions: Subjects who have experienced acute coronary syndrome (unstable angina, myocardial infarction), undergone coronary artery bypass surgery, or had other major cardiac events within the past 3 months. Subjects with severe arrhythmias (such as third-degree atrioventricular block, uncontrolled ventricular tachycardia, sick sinus syndrome, etc.) or heart failure (NYHA functional class III-IV). Subjects with uncontrolled hypertension (systolic blood pressure >= 180 mmHg and/or diastolic blood pressure >= 110 mmHg). (2) Psychological-related conditions: Subjects currently suffering from severe depressive disorder, psychotic disorder, bipolar disorder, substance abuse or dependence. Subjects with clear suicidal attempts or suicide risk (determined through clinical assessment). Subjects undergoing standardized psychological treatment (such as cognitive behavioral therapy), or having adjusted the type or dosage of anti-anxiety/anti-depressant medications within 1 month before enrollment. (3) Other comorbidities: Subjects with severe pulmonary ventilation dysfunction (such as COPD GOLD stage 3 or above), severe renal insufficiency (eGFR < 30 mL/min/1.73m^2), severe liver dysfunction (Child-Pugh class B or C), or other severe systemic diseases, which, in the investigator's judgment, make them unsuitable for participation in this study. Subjects with cognitive or physiological impairments that affect the performance of respiratory training (such as moderate or severe dementia, severe hearing impairment). (4) General conditions: Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. Subjects simultaneously participating in other experimental clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication Adherence (MMAS-8 Score); | — |
Secondary
| Measure | Time frame |
|---|---|
| Psychological Scale Indices (GAD-7, CAQ, SEMCD);Physiological Index (Heart Rate Variability, HRV);Safety Outcomes (including Adverse Events, AE, and Serious Adverse Events, SAE);System availability (Intervention Group only 1- software-based digital breathing training group); | — |
Countries
China
Contacts
Public ContactPeng Juan
Zhongshan Hospital, Fudan University
Outcome results
None listed