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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRIC+MFT | Experimental | CIRC: 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 compressed for 6 minutes per cycle, and the rest is 4 minutes per cycle. Perform twice daily, with 4 cycles per session. MFT: 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. |
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| Control (neither CRIC nor MFT). | Sham Comparator | Sham CRIC: The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group. Perform twice daily, with 4 cycles per session. 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), excludingmindfulness-specific techniques (no present-moment/ nonjudgmental awareness training, no breath-focused meditation, no open monitoring). |
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| CRIC+sham MFT | Sham Comparator | CIRC: 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 compressed for 6 minutes per cycle, and the rest is 4 minutes per cycle. Perform twice daily, with 4 cycles per session. 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), excludingmindfulness-specific techniques (no present-moment/ nonjudgmental awareness training, no breath-focused meditation, no open monitoring). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CRIC | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of MACE | Clinical events were defined as: cardiac death, nonfatal myocardial infarction, hospitalization for new heart failure,hospitalization for angina pectoris | 3,6,9,12,24months |
| Incidence of Cardiac Death |
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Inclusion Criteria:
Exclusion Criteria:
• Age < 18 years old
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Quan Guo | Contact | 15670510031 | xinyiguoquan@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Muwei LI | Fuwai Central China of Cardiovascular Hospital | Study Chair |
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| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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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 myocardial flow reserve 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.
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| sham CRIC+MFT | Sham Comparator | Sham CRIC: The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as those of the CIRC group. Perform twice daily, with 4 cycles per session. MFT: 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. |
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| MFT | Behavioral | 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. |
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| sham CIRC | Device | The pressure was 60mmHg when the cuff was pressurized, and the other modes were the same as in the CIRC group. |
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| sham MFT | Behavioral | 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). |
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Death is considered cardiac unless there is clear evidence of non-cardiac death
| 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 | 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 | 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 | 3,6,9,12,24months |
| Incidence of unplanned revascularisation | Unplanned revascularisation | 3,6,9,12,24months |
| Incidence of all cause death | Death from any cause | 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 | 3,6,9,12,24months |
| Medical expenses due to coronary heart disease | Refers to medical expenses incurred as a result of coronary heart disease | 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. | 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). | 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). | 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. | 3,6,9,12,24months |
| Mean Nocturnal Systolic Blood Pressure | Measurement using smart wearable devices | 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. | 3,6,9,12,24months |
| average heart rate | Measurement using smart wearable devices | 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. | 3,6,9,12,24months |