Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2023-11-01
2024-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A New Cardiac Rehabilitation Treatment in the Application of Ischemic Heart Disease
NCT06681506
Early Individualized-Exercise Based Cardiac Rehabilitation Programs in Patients With Acute Myocardial Infarction
NCT04511182
Formulation and Efficacy of Exercise Prescription for Patients With Coronary Heart Disease
NCT04923711
Acute Hemodynamic and Biological Effects of ECP and Exercise
NCT02014090
High-intensity Inspiratory Muscle Training as a Pre-cardiac Rehabilitation in Heart Disease
NCT06127147
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control group
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.
conventional drug and exercise rehabilitation
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
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.
EECP-based rehabilitation regimen
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
conventional drug and exercise rehabilitation
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
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion 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 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
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Chongming Hospital Affiliated to Shanghai University of Health & Medicine Sciences
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yingmin Lu
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
P-ECP/TI EECP device
Shanghai, , China
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ChongmingHospital
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.