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Completed

NCT Number: NCT06877390

Effect of Enhanced External Counterpulsation

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

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Key information

Conditions

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

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

P-ECP/TI EECP device

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional drug and exercise rehabilitation

Other

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.

EECP-based rehabilitation regimen

Device

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.

Primary outcomes

  1. Comparison of baseline data

    Time frame: followed up for 6 months

    Patients' gender

  2. Comparison of baseline data

    Time frame: followed up for 6 months

    Patients' age

  3. Comparison of baseline data

    Time frame: followed up for 6 months

    Patients' body mass index

  4. Comparison of baseline data

    Time frame: followed up for 6 months

    Patients' smoking and drinking history

  5. Comparison of baseline data

    Time frame: followed up for 6 months

    Patients' comorbidities (hypertension, diabetes and hyperlipidaemia)

  6. Comparison of baseline data

    Time frame: followed up for 6 months

    Patients' infarcted vessels

  7. Comparison of baseline data

    Time frame: followed up for 6 months

    Patients' preoperative NYHA cardiac function grading

  8. Comparison of baseline data

    Time frame: followed up for 6 months

    Patients' CCS angina grading

  9. Comparison of cardiac function

    Time frame: followed up for 6 months

    In the indicators, including the CO, SV and LVEF

  10. Comparison of brain natriuretic peptide levels

    Time frame: followed up for 6 months

    BNP levels.

  11. Comparison of 6-minute walking distance

    Time frame: followed up for 6 months

    The 6MWD in the rehabilitation group.

  12. Comparison of cardiac function gradings

    Time frame: 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.

  13. Comparison of cardiac angina gradings

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences

Other

Registry information

Official study title

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

Acronym: EECP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 14, 2025
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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