Effect of Enhanced External Counterpulsation (EECP)

Effect of Enhanced External Counterpulsation on the Rehabilitation of Patients With Acute Myocardial Infarction After Drug-Coated Balloon-Based Percutaneous Coronary Intervention

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

Study Overview

• Status: Completed
• Conditions: Cardiac Rehabilitation; Drug-coated Balloon; Acute Myocardial Infarction (AMI); Enhanced External Counterpulsation (EECP)
• Intervention / Treatment: Other: conventional drug and exercise rehabilitation; Device: EECP-based rehabilitation regimen

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • P-ECP/TI EECP device

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; 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.	Other: conventional 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.
Experimental: Rehabilitation group; 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.	Device: EECP-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: February 12, 2025
• First Submitted That Met QC Criteria: March 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 13, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Necrosis; Myocardial Ischemia; Ischemia; Myocardial Infarction; Infarction
• Other Study ID Numbers: ChongmingHospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No