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This study evaluated the efficacy and safety of enhanced extracorporeal counterpulsation for cardiac rehabilitation in patients after DCB for acute myocardial infarction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | During the observation period after undergoing DCB-based PCI, patients in the control group received antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel, once a day), β-blocker (25-100 mg of metoprolol, twice a day, with the dose adjusted based on the patient's heart rate) and statins (10-20 mg of rosuvastatin, every night). In addition, the patients received exercise rehabilitation (e.g. aerobic, resistance and flexibility training) for 30-60 min, 3-5 times/week. |
|
| Rehabilitation group | Experimental | Patients in the rehabilitation group received the same medication and exercise rehabilitation as the control group during the trial period after undergoing DCB-based PCI DCBs; in addition, they were provided with EECP treatment after 7 days of medication. The treatment adopted a P-ECP/TI EECP device with a pressure setting of 0.020-0.035 MPa. Based on patients' actual tolerance, the treatment pressure and inflation and exhaust times were adjusted to a diastolic/systolic blood pressure ratio of >1.2 and a diastolic/systolic pressure area of 1.5-2.0. The treatment was applied daily for 1 hour, 6 days a week, for a total of 36 hours. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| conventional drug and exercise rehabilitation | Other | patients in the control group received antiplatelet agents (100 mg of aspirin and 75 mg of clopidogrel, once a day), β-blocker (25-100 mg of metoprolol, twice a day, with the dose adjusted based on the patient's heart rate) and statins (10-20 mg of rosuvastatin, every night). In addition, the patients received exercise rehabilitation (e.g. aerobic, resistance and flexibility training) for 30-60 min, 3-5 times/week. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of baseline data | Patients' gender | followed up for 6 months |
| Comparison of baseline data | Patients' age | followed up for 6 months |
| Comparison of baseline data | Patients' body mass index | followed up for 6 months |
| Comparison of baseline data | Patients' smoking and drinking history | followed up for 6 months |
| Comparison of baseline data | Patients' comorbidities (hypertension, diabetes and hyperlipidaemia) | followed up for 6 months |
| Comparison of baseline data | Patients' infarcted vessels | followed up for 6 months |
| Comparison of baseline data | Patients' preoperative NYHA cardiac function grading | followed up for 6 months |
| Comparison of baseline data | Patients' CCS angina grading | followed up for 6 months |
| Comparison of cardiac function |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P-ECP/TI EECP device | Shanghai | China |
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| EECP-based rehabilitation regimen | Device | Patients in the rehabilitation group received the same medication and exercise rehabilitation as the control group during the trial period after undergoing DCB-based PCI DCBs; in addition, they were provided with EECP treatment after 7 days of medication. The treatment adopted a P-ECP/TI EECP device with a pressure setting of 0.020-0.035 MPa. Based on patients' actual tolerance, the treatment pressure and inflation and exhaust times were adjusted to a diastolic/systolic blood pressure ratio of >1.2 and a diastolic/systolic pressure area of 1.5-2.0. The treatment was applied daily for 1 hour, 6 days a week, for a total of 36 hours. |
|
In the indicators, including the CO, SV and LVEF |
| followed up for 6 months |
| Comparison of brain natriuretic peptide levels | BNP levels. | followed up for 6 months |
| Comparison of 6-minute walking distance | The 6MWD in the rehabilitation group. | followed up for 6 months |
| Comparison of cardiac function gradings | The New York Heart Association(NYHA )scale classifies impaired heart function into four levels according to the degree of activity that triggers symptoms of heart failure. A higher grade indicates more severe symptoms. | followed up for 6 months |
| Comparison of cardiac angina gradings | The Canadian Cardiovascular Society (CCS) grading system for angina pectoris is divided into four levels, with different treatment options. A higher grade indicates more severe symptoms. | followed up for 6 months |
| ID | Term |
|---|---|
| D005081 | Exercise Therapy |
| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
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