A Clinical Study of the Efficacy of Cardiovascular Ultrasound Therapy on the Rehabilitation of Patients After PCI for Coronary Artery Disease
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Coronary Heart Disease
- Sponsor
- Qilu Hospital of Shandong University
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- high-sensitivity C-reactive protein (hs-CRP) in serum
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
high-sensitivity C-reactive protein (hs-CRP) in serum
Time Frame: Day 11 after PCI
High-sensitivity C-reactive protein (hs-CRP) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions.
Interleukin-6 (IL-6) levels
Time Frame: Day 11 after PCI
high-sensitivity C-reactive protein (hs-CRP) and Interleukin-6 (IL-6) levels in serum following 20 cardiovascular ultrasound therapy treatment sessions
Secondary Outcomes
- apolipoprotein A(From enrollment to the end of treatment at 3rd month)
- Stroke Volume Index(From enrollment to the end of treatment at 3rd month)
- Stroke Volume(From enrollment to the end of treatment at 3rd month)
- creatine kinase isoenzymes(From enrollment to the end of treatment at 3rd month)
- cardiac troponin I(From enrollment to the end of treatment at 3rd month)
- myeloperoxidase(From enrollment to the end of treatment at 3rd month)
- total cholesterol(From enrollment to the end of treatment at 3rd month)
- triglyceride(From enrollment to the end of treatment at 3rd month)
- low-density lipoprotein cholesterol(From enrollment to the end of treatment at 3rd month)
- high-density lipoprotein cholesterol(From enrollment to the end of treatment at 3rd month)
- apolipoprotein B(From enrollment to the end of treatment at 3rd month)
- lipoprotein (a)(From enrollment to the end of treatment at 3rd month)
- oxidized low-density lipoprotein(From enrollment to the end of treatment at 3rd month)
- endothelial nitric oxide synthase(From enrollment to the end of treatment at 3rd month)
- endothelin-1(From enrollment to the end of treatment at 3rd month)
- vascular endothelial growth factor(From enrollment to the end of treatment at 3rd month)
- procalcitonin(From enrollment to the end of treatment at 3rd month)
- Systemic Vascular Resistance(From enrollment to the end of treatment at 3rd month)
- Mean Arterial Pressure(From enrollment to the end of treatment at 3rd month)
- Cardiac Output(From enrollment to the end of treatment at 3rd month)
- Cardiac Index(From enrollment to the end of treatment at 3rd month)
- Left Ventricular Stroke Work Index(From enrollment to the end of treatment at 3rd month)
- Systemic Vascular Resistance Index(From enrollment to the end of treatment at 3rd month)
- Ejection Phase Contraction Index(From enrollment to the end of treatment at 3rd month)
- Inotropic State Index(From enrollment to the end of treatment at 3rd month)
- Vascular Resistance(From enrollment to the end of treatment at 3rd month)
- Mean Heart Rate(From enrollment to the end of treatment at 3rd month)
- left ventricular ejection fraction(From enrollment to the end of treatment at 3rd month)
- Wall thickening fraction(From enrollment to the end of treatment at 3rd month)
- E/E'(From enrollment to the end of treatment at 3rd month)
- 6-minute walk test(From enrollment to the end of treatment at 3rd month)
- Patient Health Questionnaire-9(From enrollment to the end of treatment at 3rd month)
- 7-item Generalized Anxiety Disorder Scale(From enrollment to the end of treatment at 3rd month)
- The Pittsburgh Sleep Quality Index (PSQI)(From enrollment to the end of treatment at 3rd month)
- Seattle Angina Questionnaire (SAQ)(From enrollment to the end of treatment at 3rd month)
- Heart rate variability(From enrollment to the end of treatment at 3rd month)