NCT06877390

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 14, 2025

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

February 12, 2025

Last Update Submit

March 13, 2025

Conditions

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

Outcome Measures

Primary Outcomes (13)

  • 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

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Rehabilitation group

EXPERIMENTAL

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

Interventions

conventional drug and exercise rehabilitationOTHER

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.

Control group
EECP-based rehabilitation regimenDEVICE

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.

Rehabilitation group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

P-ECP/TI EECP device

Shanghai, China

Location

MeSH Terms

Interventions

Exercise Therapy

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2025

First Posted

March 14, 2025

Study Start

November 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)