Clinical trial NCT06877390: Effect of Enhanced External Counterpulsation
Official title: Effect of Enhanced External Counterpulsation on the Rehabilitation of Patients With Acute Myocardial Infarction After Drug-Coated Balloon-Based Percutaneous Coronary Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhanced External Counterpulsation (EECP)
Acute Myocardial Infarction (AMI)
Drug-coated Balloon
Cardiac Rehabilitation
Lead sponsor: Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences
Sponsor class: OTHER
First posted: 2025-03-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of baseline data
timeFrame: followed up for 6 months
measure: Comparison of baseline data
timeFrame: followed up for 6 months
measure: Comparison of baseline data
timeFrame: followed up for 6 months
measure: Comparison of baseline data
timeFrame: followed up for 6 months
measure: Comparison of baseline data
timeFrame: followed up for 6 months
measure: Comparison of baseline data
timeFrame: followed up for 6 months
measure: Comparison of baseline data
timeFrame: followed up for 6 months
measure: Comparison of baseline data
timeFrame: followed up for 6 months
measure: Comparison of cardiac function
timeFrame: followed up for 6 months
measure: Comparison of brain natriuretic peptide levels
timeFrame: followed up for 6 months
measure: Comparison of 6-minute walking distance
timeFrame: followed up for 6 months
measure: Comparison of cardiac function gradings
timeFrame: followed up for 6 months
measure: Comparison of cardiac angina gradings
timeFrame: followed up for 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: P-ECP/TI EECP device
Study officials:
References: