Effect of Enhanced External Counterpulsation

Not Applicable

Completed

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

• Registration Number: NCT06877390
• Lead Sponsor: Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-11-01
• Primary Completion: 2024-04-30
• Study Completion: 2024-04-30
• Study First Submitted: 2025-02-12
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-13
• Last Update Submitted: 2025-03-13
• Study First Posted: 2025-03-14
• Last Update Posted: 2025-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Comparison of baseline data	followed up for 6 months	Patients' CCS angina grading
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.

Trial Locations

Locations (1)

P-ECP/TI EECP device; 🇨🇳 Shanghai, China