Coronary Artery Disease
Conditions
Brief summary
The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can reduce cardiovascular adverse events in patients with incomplete revascularization of coronary artery disease.
Interventions
DEVICEchronic remote ischemic conditioning
Using a semi-automated machine, the pressure is increased according to the patient's own blood pressure level (20-40mmHg) when the cuff is pressed, and the pressure is squeezed for 6 minutes per cycle and the rest is 4 minutes, for a total of 4 cycles per cycle.
BEHAVIORALMindfulness Therapy
Participants receive guided mindfulness audio sessions twice daily for \~30 minutes each throughout the perioperative period. Content includes standardized mindfulness practices (e.g., focused attention, body awareness, nonjudgmental observation) designed to reduce anxiety and improve sleep quality.
OTHERsham CRIC
The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group.
BEHAVIORALsham MFT
Sham MFT: Health Education + Relaxation (HER): A time- and attention-matched audio program (twice daily, 30 minutes) delivering perioperative recovery and sleep-hygiene education with passive relaxation (music or simple muscle loosening), excluding mindfulness-specific techniques (no present-moment/nonjudgmental awareness training, no breath-focused meditation, no open monitoring).
Sponsors
Henan Institute of Cardiovascular Epidemiology
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
This study adopts a 2×2 factorial randomized controlled trial design to evaluate the independent and combined effects of chronic remote ischemic preconditioning (CRIC) and mindfulness therapy (MFT) on anxiety and sleep quality in patients with coronary heart disease. Participants will be randomly assigned to one of four groups: (1) CRIC plus MFT, (2) CRIC only, (3) MFT only, or (4) neither intervention (control). The design allows the assessment of the main effects of RIPC and MBT, as well as the potential interaction effect between the two interventions.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\) Age ≥18 years old * 2\) Consistent with the diagnosis of coronary heart disease, complete revascularization was not performed (coronary angiography showed that at least one vessel with a reference diameter of 3.0mm had stenosis greater than 90%, and quantitative flow ratio (QFR) \< 0.80) * 3\) Symptoms of myocardial ischemia (resting or exertional angina; Angina allele: chest tightness, shortness of breath, etc.);
Exclusion criteria
* Age \< 18 years old * Heart failure patients with NYHA class IV, or left ventricular ejection fraction (LVEF) \< 30% * Creatinine clearance \<15 mL/min (or eGFR \< 15 mL/min/1.73m²), or requires dialysis * Myocardial diseases such as hypertrophic cardiomyopathy, dilated cardiomyopathy, etc. * Uncontrolled or recurrent arrhythmic events (e.g., ventricular fibrillation, recurrent or symptomatic sustained ventricular tachycardia, complete heart block, atrial fibrillation with rapid ventricular rates, supraventricular tachycardia refractory to drugs) * Poorly controlled hypertension (SBP \> 180 mm Hg or DBP \> 110 mm Hg) * Active liver disease or persistent ALT or AST elevation ≥ 3 times the upper limit of normal * Unexplained CK \> 5 times the upper limit of normal, or elevated CK due to known muscle disease * Planned or anticipated cardiac surgery or revascularization before randomization * History of active malignancy (surgery, radiation therapy, and/or systemic therapy within the past 3 years) * Diagnosed or suspected upper extremity vascular malformations, aneurysms, arteriovenous fistulas, or thrombosis * Hearing impairment, unable to undergo mindfulness therapy * Currently participating in another drug or device study, or within 30 days of completing another drug or device study or receiving another investigational drug * Any life-threatening comorbid conditions expected to result in death within the next year (excluding cardiovascular diseases) * Alcoholism, substance abuse history; and unwilling or unable to stop alcohol or substance abuse during the study * History of major organ transplant (e.g., lung, liver, heart, bone marrow, kidney) * Investigator's judgment of known major active and uncontrolled disease, or any medical, physical, or surgical conditions (e.g., infection, significant blood, kidney, metabolic, gastrointestinal, or endocrine dysfunction) that may interfere with participation in the clinical study * As known to the investigator, the subject is unlikely to complete follow-up for more than 1 year or is expected to be unable to comply with the study requirements or understand the study's objectives and potential risks.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of MACE | 12 months | Clinical events were defined as: cardiac death, nonfatal myocardial infarction, hospitalization for new heart failure, hospitalization for angina pectoris |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Cardiac Death | 3，6，9，12，24months | Death is considered cardiac unless there is clear evidence of non-cardiac death |
| Incidence of Non-fatal Myocardial Infarction | 3，6，9，12，24months | Includes STEMI and NSTEMI with elevated serum troponin on the basis of patient symptoms or ECG changes |
| Incidence of hospitalisation for new-onset heart failure | 3，6，9，12，24months | New onset of heart failure-related symptoms with elevated serum BNP or NT-ProBNP |
| Incidence of hospitalised for angina pectoris | 3，6，9，12，24months | Hospitalisation for angina pectoris symptoms of all causes, with a discharge diagnosis of angina pectoris |
| Incidence of unplanned revascularisation | 3，6，9，12，24months | Unplanned revascularisation |
| Incidence of all cause death | 3，6，9，12，24months | Death from any cause |
| Incidence of total length of hospitalization due to coronary heart disease | 3，6，9，12，24months | Refers to the number of days when all hospitalizations for all causes of coronary heart disease are stacked together |
| Medical expenses due to coronary heart disease | 3，6，9，12，24months | Refers to medical expenses incurred as a result of coronary heart disease |
| Degree of improvement in angina symptoms | 3，6，9，12，24months | The degree of improvement in angina symptoms will be assessed using the Seattle Angina Questionnaire (SAQ), a 19-item self-administered questionnaire that evaluates five domains of health status in patients with coronary artery disease: physical limitation (9 items), angina stability (1 item), angina frequency (2 items), treatment satisfaction (4 items), and disease perception (3 items). Each domain score ranges from 0 to 100, with higher scores indicating better function (e.g., less physical limitation, less frequent angina, and better quality of life). A summary score, averaging the physical limitation, angina frequency, and quality of life domains, also ranges from 0 to 100. Improvement will be measured as the change in SAQ domain scores and summary score from baseline to follow-up time points, where an increase of 10 points or more in any domain or the summary score is considered clinically significant. |
| Change in anxiety scores | 3，6，9，12，24months | Changes in anxiety scores will be assessed using the Zung Self-Rating Anxiety Scale (SAS), a 20-item self-report questionnaire that measures anxiety symptoms across cognitive, autonomic, motor, and central nervous system domains. Each item is rated on a 4-point Likert scale (1 = "none or a little of the time" to 4 = "most or all of the time"), yielding a raw total score ranging from 20 to 80, with higher scores indicating greater anxiety severity. Raw scores can be converted to an index score by multiplying by 1.25 (range: 25 to 100). The change in anxiety scores will be calculated as the difference in raw SAS scores from baseline to follow-up time points. For reference, raw scores are typically interpreted as: \<36 (normal), 36-47 (mild anxiety), 48-59 (moderate anxiety), and ≥60 (severe anxiety). |
| Change in depression scores | 3，6，9，12，24months | Changes in depression scores will be assessed using the Zung Self-Rating Depression Scale (SDS), a 20-item self-report questionnaire that measures depressive symptoms across affective, psychological, and somatic domains. Each item is rated on a 4-point Likert scale (1 = "none or a little of the time" to 4 = "most or all of the time"), yielding a raw total score ranging from 20 to 80, with higher scores indicating greater depression severity. Raw scores can be converted to an index score by multiplying by 1.25 (range: 25 to 100). The change in depression scores will be calculated as the difference in raw SDS scores from baseline to follow-up time points. For reference, raw scores are typically interpreted as: \<40 (normal), 40-47 (mild depression), 48-55 (moderate depression), and ≥56 (severe depression). |
| Changes in sleep quality | 3，6，9，12，24months | Changes in sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a 19-item self-report questionnaire that evaluates sleep quality over the past month across seven components: subjective sleep quality (1 item), sleep latency (2 items), sleep duration (1 item), habitual sleep efficiency (3 items), sleep disturbances (9 items), use of sleeping medication (1 item), and daytime dysfunction (2 items). Each component is scored from 0 to 3, with higher scores indicating greater dysfunction. The global PSQI score is the sum of the seven components and ranges from 0 to 21, with higher scores indicating poorer sleep quality. Changes in sleep quality will be calculated as the difference in global PSQI scores from baseline to follow-up time points. For reference, a global score \>5 is indicative of poor sleep quality. |
Countries
China
Contacts
CONTACTQuan Guo, MD
STUDY_CHAIRMuwei LI, MD
Fuwai Central China of Cardiovascular Hospital
Outcome results
None listed