Effect of Enhanced External Counterpulsation (EECP)

Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences

Status: Completed

Conditions: Cardiac Rehabilitation; Drug-coated Balloon; Acute Myocardial Infarction (AMI); Enhanced External Counterpulsation (EECP)

Treatments: Device: EECP-based rehabilitation regimen; Other: conventional drug and exercise rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06877390

ChongmingHospital

Details and patient eligibility

About

This study evaluated the efficacy and safety of enhanced extracorporeal counterpulsation for cardiac rehabilitation in patients after DCB for acute myocardial infarction.

Enrollment: 60 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control group

Active Comparator group

Description:

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.

Treatment:

Other: conventional drug and exercise rehabilitation

Rehabilitation group

Experimental group

Description:

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.

Treatment:

Device: EECP-based rehabilitation regimen