Status:

COMPLETED

Effect of Enhanced External Counterpulsation

Lead Sponsor:

Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences

Conditions:

Enhanced External Counterpulsation (EECP)

Acute Myocardial Infarction (AMI)

Eligibility:

All Genders

18-75 years

Phase:

NA

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

  • 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

  • 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

Key Trial Info

Start Date :

November 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 30 2024

Estimated Enrollment :

60 Patients enrolled

Trial Details

Trial ID

NCT06877390

Start Date

November 1 2023

End Date

April 30 2024

Last Update

March 14 2025

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P-ECP/TI EECP device

Shanghai, China