Acute Myocardial Infarction (AMI), Cardiac Rehabilitation, Drug-coated Balloon, Enhanced External Counterpulsation (EECP)
Conditions
Brief summary
This study evaluated the efficacy and safety of enhanced extracorporeal counterpulsation for cardiac rehabilitation in patients after DCB for acute myocardial infarction.
Interventions
OTHERconventional drug and exercise rehabilitation
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.
DEVICEEECP-based rehabilitation regimen
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.
Sponsors
Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients with AMI diagnosed based on the universal definition of myocardial infarction criteria * a single vessel infarcted, and Syntax score ≤22 * patients treated using DCB * patients without EECP contraindications * patients aged 18-75 years * patients who had signed informed consent and were able to cooperate in completing the study
Exclusion criteria
* patients with lower limb deep venous thrombosis and active thrombophlebitis * patients with moderate to severe valvular heart disease, especially those with aortic insufficiency and/or stenosis * patients with moderate to severe pulmonary arterial hypertension (mean pulmonary arterial pressure \>50 mmHg) * patients with aortic, cerebral or dissecting aneurysms * patients with uncontrolled hypertension (\>180/110 mmHg) * patients with decompensated heart failure (cardiac function of grade IV) * patients with arrhythmia that might interfere with the electrocardiographic gating function of the EECP device * patients with haemorrhagic diseases or obvious bleeding tendencies * patients with infected lesions in their limbs that may affect EECP * pregnant women * patients with ventricular aneurysm and mural thrombus detected through echocardiography
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of baseline data | followed up for 6 months | Patients' gender |
| Comparison of cardiac function | followed up for 6 months | In the indicators, including the CO, SV and LVEF |
| Comparison of brain natriuretic peptide levels | followed up for 6 months | BNP levels. |
| Comparison of 6-minute walking distance | followed up for 6 months | The 6MWD in the rehabilitation group. |
| Comparison of cardiac function gradings | followed up for 6 months | 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. |
| Comparison of cardiac angina gradings | followed up for 6 months | 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. |
Countries
China
Outcome results
None listed