Enhanced External Counterpulsation (EECP)EECPNCT06877390
Effect of Enhanced External Counterpulsation
A study testing conventional drug and exercise rehabilitation and EECP-based rehabilitation regimen in people with Enhanced External Counterpulsation (EECP) and Acute Myocardial Infarction (AMI), run by Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences at 1 site in China.
Trial summary
This study evaluated the efficacy and safety of enhanced extracorporeal counterpulsation for cardiac rehabilitation in patients after DCB for acute myocardial infarction. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Enhanced External Counterpulsation (EECP), Acute Myocardial Infarction (AMI), Drug-coated Balloon
- What is being tested?
- conventional drug and exercise rehabilitation and EECP-based rehabilitation regimen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Enhanced External Counterpulsation (EECP), Acute Myocardial Infarction (AMI), Drug-coated Balloon, Cardiac Rehabilitation
- Being tested
- conventional drug and exercise rehabilitation, EECP-based rehabilitation regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: EECP-based rehabilitation regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of baseline data
Patients' gender
Measured: followed up for 6 months
Comparison of baseline data
Patients' age
Measured: followed up for 6 months
Comparison of baseline data
Patients' body mass index
Measured: followed up for 6 months
Comparison of baseline data
Patients' smoking and drinking history
Measured: followed up for 6 months
Comparison of baseline data
Patients' comorbidities (hypertension, diabetes and hyperlipidaemia)
Measured: followed up for 6 months
Comparison of baseline data
Patients' infarcted vessels
Measured: followed up for 6 months
Comparison of baseline data
Patients' preoperative NYHA cardiac function grading
Measured: followed up for 6 months
Comparison of baseline data
Patients' CCS angina grading
Measured: followed up for 6 months
Comparison of cardiac function
In the indicators, including the CO, SV and LVEF
Measured: followed up for 6 months
Comparison of brain natriuretic peptide levels
BNP levels.
Measured: followed up for 6 months
Comparison of 6-minute walking distance
The 6MWD in the rehabilitation group.
Measured: 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.
Measured: 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.
Measured: followed up for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2025
- Study start1 Nov 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced External Counterpulsation (EECP)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingmin Lu, Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06877390
- Sponsor's protocol ID
- ChongmingHospital
- Acronym
- EECP
- Status last verified
- Mar 2025
- First submitted
- 12 Feb 2025
- Last updated
- 14 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Enhanced External Counterpulsation on the Rehabilitation of Patients With Acute Myocardial Infarction After Drug-Coated Balloon-Based Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT06877390
- Acronym / sponsor ID
- EECP / ChongmingHospital
- Conditions
- Enhanced External Counterpulsation (EECP), Acute Myocardial Infarction (AMI), Drug-coated Balloon, Cardiac Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Chongming Hospital Affiliated to Shanghai University of Health & Medicine SciencesUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluated the efficacy and safety of enhanced extracorporeal counterpulsation for cardiac rehabilitation in patients after DCB for acute myocardial infarction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: conventional drug and exercise rehabilitationDuring 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. |
| Rehabilitation group | Experimental | Device: EECP-based rehabilitation regimenPatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional drug and exercise rehabilitationpatients 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 | Control group |
| EECP-based rehabilitation regimenPatients 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 | Rehabilitation group |
Primary outcome
Comparison of baseline data
Time frame: followed up for 6 months
Patients' gender
Comparison of baseline data
Time frame: followed up for 6 months
Patients' age
Comparison of baseline data
Time frame: followed up for 6 months
Patients' body mass index
Comparison of baseline data
Time frame: followed up for 6 months
Patients' smoking and drinking history
Comparison of baseline data
Time frame: followed up for 6 months
Patients' comorbidities (hypertension, diabetes and hyperlipidaemia)
Comparison of baseline data
Time frame: followed up for 6 months
Patients' infarcted vessels
Comparison of baseline data
Time frame: followed up for 6 months
Patients' preoperative NYHA cardiac function grading
Comparison of baseline data
Time frame: followed up for 6 months
Patients' CCS angina grading
Comparison of cardiac function
Time frame: followed up for 6 months
In the indicators, including the CO, SV and LVEF
Comparison of brain natriuretic peptide levels
Time frame: followed up for 6 months
BNP levels.
Comparison of 6-minute walking distance
Time frame: followed up for 6 months
The 6MWD in the rehabilitation group.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional drug and exercise rehabilitation and EECP-based rehabilitation regimen in people with Enhanced External Counterpulsation (EECP) and Acute Myocardial Infarction (AMI), run by Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of baseline data (time frame: followed up for 6 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2025.