The main objective of this study is to demonstrate whether the combination of chronic remote ischemic conditioning and mindfulness therapy can improve myocardial flow reserve in patients with incomplete revascularization of coronary artery disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
480
chronic 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.
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.
The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as in the CIRC group.
Change in Myocardial Flow Reserve (MFR)
Change in myocardial flow reserve (MFR) assessed by CT myocardial perfusion imaging from baseline to 6 months after randomization.
Time frame: 6 months
Incidence of MACE
Clinical events were defined as: cardiac death, nonfatal myocardial infarction, hospitalization for new heart failure,hospitalization for angina pectoris
Time frame: 3，6，9，12，24months
Incidence of Cardiac Death
Death is considered cardiac unless there is clear evidence of non-cardiac death
Time frame: 3，6，9，12，24months
Incidence of Non-fatal Myocardial Infarction
Includes STEMI and NSTEMI with elevated serum troponin on the basis of patient symptoms or ECG changes
Time frame: 3，6，9，12，24months
Incidence of hospitalisation for new-onset heart failure
New onset of heart failure-related symptoms with elevated serum BNP or NT-ProBNP
Time frame: 3，6，9，12，24months
Incidence of hospitalised for angina pectoris
Hospitalisation for angina pectoris symptoms of all causes, with a discharge diagnosis of angina pectoris
Time frame: 3，6，9，12，24months
Incidence of unplanned revascularisation
Unplanned revascularisation
Time frame: 3，6，9，12，24months
Incidence of all cause death
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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).
Death from any cause
Time frame: 3，6，9，12，24months
Incidence of total length of hospitalization due to coronary heart disease
Refers to the number of days when all hospitalizations for all causes of coronary heart disease are stacked together
Time frame: 3，6，9，12，24months
Medical expenses due to coronary heart disease
Refers to medical expenses incurred as a result of coronary heart disease
Time frame: 3，6，9，12，24months
Degree of improvement in angina symptoms
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.
Time frame: 3，6，9，12，24months
Change in anxiety scores
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).
Time frame: 3，6，9，12，24months
Change in depression scores
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).
Time frame: 3，6，9，12，24months
Changes in sleep quality
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 omponents 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.
Time frame: 3，6，9，12，24months
Mean Nocturnal Systolic Blood Pressure
Measurement using smart wearable devices
Time frame: 3，6，9，12，24months
Average sleep duration (hours per night)
Average total sleep time per night, measured using a smart wearable device. Data will be reported as mean (±SD) hours per night.
Time frame: 3，6，9，12，24months
average heart rate
Measurement using smart wearable devices
Time frame: 3，6，9，12，24months
Sleep quality (measured by sleep efficiency, %)
Sleep efficiency (%) assessed using a smart wearable device, defined as the ratio of total sleep time to time in bed. Data will be reported as mean (±SD) percentage. Higher values indicate better sleep quality.
Time frame: 3，6，9，12，24months