NCT06640400

Cardiovascular Ultrasound for the Rehabilitation of Patients With Coronary Heart Disease After PCI

A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Qilu Hospital of Shandong University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn the efficacy of cardiovascular ultrasound therapy on the rehabilitation of patients with coronary heart disease after PCI. It will also learn about the safety of cardiovascular ultrasound. The main questions it aims to answer are: Whether cardiovascular ultrasound improves cardiac function and prognosis in patients with coronary artery disease after PCI? What medical problems will participants experience after using cardiovascular ultrasound therapy? Researchers will compare cardiovascular ultrasound to a placebo (sham stimulation) to see if cardiovascular ultrasound works to treat coronary artery disease after PCI. Participants will: Patients were treated with cardiovascular ultrasound or placebo from the 24th hour after PCI for 20 minutes twice a day for 10 days. Examination and detection of serum inflammatory markers, endothelial function indicators, cardiac function, and heart rate variability at multiple time points (baseline (24 hours post-PCI), days 5 and 10 post-intervention, and months 1 and 3. Their symptoms were recorded, and depression and anxiety were scored.

Detailed description

Background Coronary heart disease (CHD) is one of the leading causes of mortality and disability and places a financial burden on the healthcare system. Although cardiovascular ultrasound has shown its effectiveness and safety in improving refractory angina, relevant clinical studies are rare, and clinical evidence is severely lacking. Methods and design This is a prospective, parallel-group, randomized control trial. We will enroll 200 patients with coronary artery disease after PCI and randomize them into 2 groups. The intervention group was given usual practice combined with cardiovascular ultrasound intervention and the control group was given usual practice combined with empty stimulation intervention. We used hs-CRP and IL-6 levels in serum after 20 times treatments with LIPUS as the primary outcome measures. Serum myocardial injury indicators levels and blood lipids indicators levels, markers of endothelial function levels, inflammatory factor levels, hemodynamic Indicators, Echocardiogram, 6-minute walk test, Short-term Heart rate variability, and mental health assessment were secondary outcomes. The researchers tested the outcome indicators at baseline (24th hours after PCI), 5th and 10th days, and 1st and 3rd months after the intervention. Statistical analyses were performed using SPSS 26.0 statistical software. Discussion This study is the first clinical study of the rehabilitation efficacy of cardiovascular ultrasound in the treatment of coronary heart disease after PCI. Given that the current clinical recovery mainly depends on the body's self-limiting and conventional symptomatic treatment, Cardiovascular ultrasound, as a new therapy method, might be a major advance in the treatment of coronary heart disease after PCI.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	Cardiovascular ultrasound	Participants in the intervention group will be treated with a medical LIPUS device (838C-M-L-I/II, Shenzhen, China) for 10 days in addition to conventional medical treatment. The ultrasound therapy instrument is equipped with a sound head comprising 5 transducer units, operating at an ultrasonic frequency of 0.84MHz with a sound intensity range of 1 W/cm2 -1.25 W/cm2. The therapeutic ultrasound sessions necessitate a controlled environmental temperature. Patients will assume the supine position, exposing the precordial region, with the five-pronged head positioned parallel to the heart\'s long axis, covering the entire precordial region including the right and left coronary arterial trunks and the aortic root. The ultrasound therapy device operates in a pulsed mode, with each treatment session lasting 20 minutes, comprising 2 daily sessions for a total of 20 treatments.

Timeline

• Start date: 2024-10-25
• Primary completion: 2025-10-30
• Completion: 2025-10-30
• First posted: 2024-10-15
• Last updated: 2024-10-15

Locations

1 site across 1 country: China